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zanubrutinib đ¶ Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| agammaglobulinaemia tyrosine kinase (Bruton tyrosine kinase) inhibitors | 5353 | 1691249-45-2 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
BRUKINSA (zanubrutinib) is a Brutonâs tyrosine kinase (BTK) inhibitor. Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B-cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion. In nonclinical studies, zanubrutinib inhibited malignant B-cell proliferation and reduced tumor growth.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 0.32 | g | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| BDDCS (Biopharmaceutical Drug Disposition Classification System) | 2 | Bocci G, Oprea TI, Benet LZ |
Predicted pharmacokinetic/toxicological properties (PK-AZ):
| Property | Description | Value | Unit | Confidence | Similarity |
|---|---|---|---|---|---|
| kinase-safety-class | ABL2,ACVR2B,BLK,BMX,BRAF,BTK,CAMK2D,CHEK2,CSF1R,CSK,CSNK1G2,DDR1,EGFR,EIF2AK3,EPHA2,ERBB2,ERBB4,FLT3,FYN,ITK,JAK3,KDR,LCK,LYN,MAP2K1,MAP3K21,MAP4K1,MAP4K2,MAP4K3,MAPK10,MAPK7,MARK4,MET,MINK1,NTRK1,PDK1,PDK2,PDK4,RIPK3,SIK2,SIK3,SRC,STK33,SYK,TTK,YES1 | 46 | |||
| kinase-selectivity-class | BLK,BMX,BTK,CSF1R,CSK,EGFR,ERBB2,ERBB4,FYN,JAK3,LYN,MAP2K1,MINK1,RIPK3,YES1 | 15 | |||
| mdck-mdr1-bcrp-efflux | MDCK-MDR1-BCRP efflux ratio | 13.459 | High | 1 | |
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 | |||
| rat-kpuu-brain | Rat brain Kpuu | 0.012 | % | High | 1 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Nov. 14, 2019 | FDA | BEIGENE USA INC | |
| Nov. 22, 2021 | EMA | BEIGENE IRELAND LTD |
FDA Adverse Event Reporting System (Female)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Cytokine increased | 225.33 | 44.36 | 26 | 1396 | 80 | 90626945 |
| Lymphocyte count decreased | 132.58 | 44.36 | 40 | 1382 | 35010 | 90592015 |
| Myelosuppression | 123.70 | 44.36 | 42 | 1380 | 53549 | 90573476 |
| N-terminal prohormone brain natriuretic peptide increased | 107.58 | 44.36 | 21 | 1401 | 2941 | 90624084 |
| Cytokine release syndrome | 106.05 | 44.36 | 32 | 1390 | 27941 | 90599084 |
| Neutrophil count decreased | 104.60 | 44.36 | 40 | 1382 | 71492 | 90555533 |
| White blood cell count decreased | 103.82 | 44.36 | 51 | 1371 | 167058 | 90459967 |
| Hypophosphataemia | 101.80 | 44.36 | 27 | 1395 | 14827 | 90612198 |
| Hypoalbuminaemia | 99.98 | 44.36 | 27 | 1395 | 15870 | 90611155 |
| Blood immunoglobulin G decreased | 97.93 | 44.36 | 20 | 1402 | 3518 | 90623507 |
| Platelet count decreased | 97.76 | 44.36 | 46 | 1376 | 136923 | 90490102 |
| Hypokalaemia | 63.79 | 44.36 | 34 | 1388 | 131082 | 90495943 |
| Hypomagnesaemia | 55.88 | 44.36 | 21 | 1401 | 35567 | 90591458 |
| Anaemia | 51.19 | 44.36 | 43 | 1379 | 352759 | 90274266 |
| Hypocalcaemia | 48.88 | 44.36 | 20 | 1402 | 42348 | 90584677 |
| Disseminated mucormycosis | 45.10 | 44.36 | 8 | 1414 | 663 | 90626362 |
FDA Adverse Event Reporting System (Male)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Cytokine increased | 196.08 | 41.72 | 26 | 1718 | 99 | 42619492 |
| Myelosuppression | 102.50 | 41.72 | 44 | 1700 | 40417 | 42579174 |
| Lymphocyte count decreased | 86.39 | 41.72 | 35 | 1709 | 27774 | 42591817 |
| Neutrophil count decreased | 83.64 | 41.72 | 44 | 1700 | 63371 | 42556220 |
| White blood cell count decreased | 80.23 | 41.72 | 52 | 1692 | 110344 | 42509247 |
| Cytokine release syndrome | 79.63 | 41.72 | 38 | 1706 | 44489 | 42575102 |
| Blood immunoglobulin G decreased | 76.64 | 41.72 | 18 | 1726 | 2296 | 42617295 |
| Anaemia | 76.58 | 41.72 | 74 | 1670 | 280204 | 42339387 |
| Disease progression | 70.07 | 41.72 | 53 | 1691 | 143603 | 42475988 |
| Hypoalbuminaemia | 67.49 | 41.72 | 25 | 1719 | 15585 | 42604006 |
| Hypokalaemia | 52.51 | 41.72 | 34 | 1710 | 71687 | 42547904 |
| Lymphoma transformation | 51.35 | 41.72 | 10 | 1734 | 522 | 42619069 |
| N-terminal prohormone brain natriuretic peptide increased | 50.54 | 41.72 | 14 | 1730 | 3439 | 42616152 |
| Hypophosphataemia | 50.38 | 41.72 | 22 | 1722 | 20923 | 42598668 |
| Platelet count decreased | 50.19 | 41.72 | 43 | 1701 | 138538 | 42481053 |
| Hypocalcaemia | 45.64 | 41.72 | 23 | 1721 | 30150 | 42589441 |
| Renal ischaemia | 45.00 | 41.72 | 11 | 1733 | 1659 | 42617932 |
| Hypomagnesaemia | 43.92 | 41.72 | 22 | 1722 | 28466 | 42591125 |
| C-reactive protein increased | 43.74 | 41.72 | 29 | 1715 | 63531 | 42556060 |
| Lymphadenopathy | 43.46 | 41.72 | 23 | 1721 | 33342 | 42586249 |
FDA Adverse Event Reporting System (Geriatric)
| MedDRA adverse event term | Likelihood ratio | Likelihood ratio threshold | Patients taking drug having adverse event | Patients taking drug not having adverse event | Patients not taking drug having adverse event | Patients not taking drug not having adverse event |
|---|---|---|---|---|---|---|
| Cytokine increased | 411.81 | 34.26 | 54 | 4031 | 210 | 110585004 |
| Myelosuppression | 356.94 | 34.26 | 133 | 3952 | 94207 | 110491007 |
| Lymphocyte count decreased | 258.23 | 34.26 | 92 | 3993 | 57151 | 110528063 |
| White blood cell count decreased | 243.60 | 34.26 | 133 | 3952 | 229257 | 110355957 |
| Neutrophil count decreased | 219.57 | 34.26 | 101 | 3984 | 120840 | 110464374 |
| Platelet count decreased | 204.90 | 34.26 | 119 | 3966 | 230324 | 110354890 |
| Blood immunoglobulin G decreased | 172.43 | 34.26 | 40 | 4045 | 5360 | 110579854 |
| Hypoalbuminaemia | 171.04 | 34.26 | 57 | 4028 | 28917 | 110556297 |
| Cytokine release syndrome | 163.75 | 34.26 | 70 | 4015 | 70236 | 110514978 |
| Hypophosphataemia | 148.20 | 34.26 | 53 | 4032 | 33129 | 110552085 |
| N-terminal prohormone brain natriuretic peptide increased | 141.85 | 34.26 | 35 | 4050 | 6086 | 110579128 |
| Hypokalaemia | 122.84 | 34.26 | 79 | 4006 | 182369 | 110402845 |
| Anaemia | 115.21 | 34.26 | 120 | 3965 | 546966 | 110038248 |
| Hypocalcaemia | 104.22 | 34.26 | 50 | 4035 | 65316 | 110519898 |
| Hypomagnesaemia | 101.81 | 34.26 | 48 | 4037 | 60322 | 110524892 |
| Disease progression | 99.92 | 34.26 | 78 | 4007 | 243956 | 110341258 |
| Off label use | 95.54 | 34.26 | 185 | 3900 | 1500000 | 109085214 |
| Gamma-glutamyltransferase increased | 80.19 | 34.26 | 41 | 4044 | 61268 | 110523946 |
| C-reactive protein increased | 75.05 | 34.26 | 63 | 4022 | 217856 | 110367358 |
| Lymphoma transformation | 69.82 | 34.26 | 13 | 4072 | 591 | 110584623 |
| Aspartate aminotransferase increased | 60.80 | 34.26 | 49 | 4036 | 159887 | 110425327 |
| Systemic inflammatory response syndrome | 55.05 | 34.26 | 20 | 4065 | 13023 | 110572191 |
| Granulocyte count decreased | 54.58 | 34.26 | 15 | 4070 | 3959 | 110581255 |
| Blood alkaline phosphatase increased | 53.33 | 34.26 | 33 | 4052 | 70902 | 110514312 |
| Mantle cell lymphoma recurrent | 45.80 | 34.26 | 10 | 4075 | 1016 | 110584198 |
| Serum ferritin increased | 45.69 | 34.26 | 17 | 4068 | 11830 | 110573384 |
| Alanine aminotransferase increased | 45.19 | 34.26 | 44 | 4041 | 183729 | 110401485 |
| Hypoproteinaemia | 44.41 | 34.26 | 14 | 4071 | 5931 | 110579283 |
| Renal ischaemia | 42.49 | 34.26 | 11 | 4074 | 2312 | 110582902 |
| Chest discomfort | 37.90 | 34.26 | 39 | 4046 | 173809 | 110411405 |
| Petechiae | 37.61 | 34.26 | 18 | 4067 | 23299 | 110561915 |
| Diffuse large B-cell lymphoma refractory | 36.87 | 34.26 | 10 | 4075 | 2511 | 110582703 |
| Diffuse large B-cell lymphoma recurrent | 35.57 | 34.26 | 12 | 4073 | 6287 | 110578927 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01EL03 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Bruton's tyrosine kinase (BTK) inhibitors |
| MeSH PA | D000092004 | Tyrosine Kinase Inhibitors |
| MeSH PA | D000970 | Antineoplastic Agents |
| MeSH PA | D004791 | Enzyme Inhibitors |
| MeSH PA | D006401 | Hematologic Agents |
| MeSH PA | D047428 | Protein Kinase Inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000193934 | Brutons Tyrosine Kinase Inhibitors |
| CHEBI has role | CHEBI:22587 | antiviral agent |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
| CHEBI has role | CHEBI:35705 | immunosuppressive agent |
| CHEBI has role | CHEBI:67079 | anti-inflammatory agent |
| CHEBI has role | CHEBI:75835 | anti-anaemic agent |
| CHEBI has role | CHEBI:231911 | renoprotective agent |
Related Drugs by ATC class:
L01EL Bruton's tyrosine kinase (BTK) inhibitors 4 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Chronic lymphoid leukemia, disease | indication | 92814006 | |
| Waldenström macroglobulinemia | indication | 190818004 | DOID:0050747 |
| Mantle cell lymphoma | indication | 443487006 | |
| Marginal zone lymphoma | indication | 447100004 |
đ¶ Veterinary Drug Use
None
đ¶ Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 11.85 | acidic |
| pKa2 | 2.64 | Basic |
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 10570139 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 10570139 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11142528 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11142528 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 9447106 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 9447106 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 10570139 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 10570139 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 10570139 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11142528 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11142528 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11142528 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 9447106 | April 22, 2034 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 9447106 | April 22, 2034 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 9447106 | April 22, 2034 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11884674 | Aug. 15, 2037 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11884674 | Aug. 15, 2037 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11970500 | Aug. 15, 2037 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11970500 | Aug. 15, 2037 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11591340 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11884674 | Aug. 15, 2037 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11884674 | Aug. 15, 2037 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11884674 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11970500 | Aug. 15, 2037 | FOR THE TREATMENT OF PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11970500 | Aug. 15, 2037 | RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE PRIOR ANTI-CD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11970500 | Aug. 15, 2037 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11701357 | June 24, 2039 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11701357 | June 24, 2039 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTIâCD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTIâCD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTIâCD20-BASED REGIMEN |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTIâCD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11786531 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTIâCD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11896596 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL) RECEIVING A MODERATE CYP3A INDUCER, IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) RECEIVING A MODERATE CYP3A INDUCER, WHO HAVE RECEIVED AT LEAST ONE ANTIâCD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH SMALL LYMPHOCYTIC LYMPHOMA (SLL) RECEIVING A MODERATE CYP3A INDUCER |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | 11911386 | Jan. 19, 2043 | TREATMENT OF ADULT PATIENTS WITH WALDENSTROMS MACROGLOBULINEMIA (WM) RECEIVING A MODERATE CYP3A INDUCER |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | Jan. 19, 2026 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | Jan. 19, 2026 | TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | Nov. 14, 2026 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH MANTLE CELL LYMPHOMA (MCL) WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | Nov. 14, 2026 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | March 7, 2027 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | March 7, 2027 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), IN COMBINATION WITH OBINUTUZUMAB, AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | Aug. 31, 2028 | TREATMENT OF ADULT PATIENTS WITH WALDENSTRÓŠMâS MACROGLOBULINEMIA (WM) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | Aug. 31, 2028 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | Sept. 14, 2028 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY MARGINAL ZONE LYMPHOMA (MZL) WHO HAVE RECEIVED AT LEAST ONE ANTI-CD20-BASED REGIMEN |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | Sept. 14, 2028 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | Jan. 19, 2030 | INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) OR SMALL LYMPHOCYTIC LYMPHOMA (SLL) |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | Jan. 19, 2030 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
| 80MG | BRUKINSA | BEONE MEDICINES USA | N213217 | Nov. 14, 2019 | DISCN | CAPSULE | ORAL | March 7, 2031 | TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY FOLLICULAR LYMPHOMA (FL), AFTER TWO OR MORE LINES OF SYSTEMIC THERAPY |
| 160MG | BRUKINSA | BEONE MEDICINES USA | N218785 | June 10, 2025 | RX | TABLET | ORAL | March 7, 2031 | FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S). AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S) |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Tyrosine-protein kinase BTK | Kinase | INHIBITOR | IC50 | 9.52 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Epidermal growth factor receptor | Kinase | IC50 | 8.22 | CHEMBL | |||||
| Tyrosine-protein kinase Lck | Kinase | IC50 | 6.73 | CHEMBL | |||||
| Receptor tyrosine-protein kinase erbB-2 | Kinase | Kd | 7.12 | CHEMBL | |||||
| Receptor tyrosine-protein kinase erbB-4 | Kinase | IC50 | 8.80 | CHEMBL | |||||
| Cytoplasmic tyrosine-protein kinase BMX | Kinase | IC50 | 8.27 | CHEMBL | |||||
| Tyrosine-protein kinase Fgr | Kinase | IC50 | 6.81 | CHEMBL | |||||
| Tyrosine-protein kinase JAK3 | Kinase | IC50 | 6.24 | CHEMBL | |||||
| Tyrosine-protein kinase ITK/TSK | Kinase | IC50 | 7.18 | CHEMBL | |||||
| Protein-tyrosine kinase 6 | Kinase | IC50 | 7.48 | CHEMBL | |||||
| Tyrosine-protein kinase Tec | Kinase | IC50 | 8.70 | CHEMBL | |||||
| Tyrosine-protein kinase TXK | Kinase | IC50 | 8.53 | CHEMBL | |||||
| Tyrosine-protein kinase Blk | Kinase | IC50 | 8.95 | CHEMBL | |||||
| Platelet glycoprotein VI | Membrane receptor | IC50 | 6.29 | CHEMBL | |||||
| Tyrosine-protein kinase FRK | Kinase | IC50 | 6.42 | CHEMBL |
External reference:
| ID | Source |
|---|---|
| AG9MHG098Z | UNII |
| 4038969 | VANDF |
| C4683810 | UMLSCUI |
| CHEBI:755996 | CHEBI |
| BA0 | PDB_CHEM_ID |
| CHEMBL3936761 | ChEMBL_ID |
| 135565884 | PUBCHEM_CID |
| DB15035 | DRUGBANK_ID |
| D11422 | KEGG_DRUG |
| 10555 | INN_ID |
| C000629551 | MESH_SUPPLEMENTAL_RECORD_UI |
| 9861 | IUPHAR_LIGAND_ID |
| 830103007 | SNOMEDCT_US |
| 830162004 | SNOMEDCT_US |
| 326780 | MMSL |
| 37672 | MMSL |
| d09435 | MMSL |
| 018195 | NDDF |
| 2262435 | RXNORM |
| AG9MHG098Z | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| BRUKINSA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72579-011 | CAPSULE | 80 mg | ORAL | NDA | 31 sections |
| BRUKINSA | HUMAN PRESCRIPTION DRUG LABEL | 1 | 72579-122 | TABLET, FILM COATED | 160 mg | ORAL | NDA | 31 sections |