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pemigatinib 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| tyrosine kinase inhibitors | 5390 | 1513857-77-6 |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
Pemigatinib inhibited FGFR1-3 phosphorylation and signaling and decreased cell viability in cancer cell lines with activating FGFR amplifications and fusions that resulted in constitutive activation of FGFR signaling.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
| Dose | Unit | Route |
|---|---|---|
| 9 | mg | O |
ADMET properties:
| Property | Value | Reference |
|---|---|---|
| S (Water solubility) | 0.00 mg/mL | Bocci G, Oprea TI, Benet LZ |
| 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 |
|---|---|---|---|---|---|
| pfas-class | PFAS structural alert (1 = True, 0 = False) | 0 |
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| March 26, 2021 | EMA | Incyte Biosciences Distribution B.V. | |
| March 23, 2021 | PMDA | Incyte Biosciences Japan GK | |
| April 17, 2020 | FDA | INCYTE CORP |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
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 |
|---|---|---|---|---|---|---|
| Disease progression | 142.26 | 68.46 | 48 | 397 | 243986 | 110344868 |
| Hyperphosphataemia | 72.23 | 68.46 | 16 | 429 | 16365 | 110572489 |
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| ATC | L01EN02 | ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS PROTEIN KINASE INHIBITORS Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors |
| FDA MoA | N0000175082 | Kinase Inhibitors |
| FDA EPC | N0000175605 | Kinase Inhibitor |
| FDA MoA | N0000185503 | P-Glycoprotein Inhibitors |
| FDA MoA | N0000187061 | Organic Cation Transporter 2 Inhibitors |
| FDA MoA | N0000191423 | Multidrug and Toxin Extrusion Transporter 1 Inhibitors |
| CHEBI has role | CHEBI:35610 | antineoplastic agent |
Related Drugs by ATC class:
L01EN Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors 3 drugs
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Malignant neoplasm of common bile duct (& [carcinoma]) | indication | 187785004 | |
| Biliary tract cancer | indication | 363415003 | DOID:4607 |
| FGFR1 fusion genepositive myeloid/lymphoid neoplasm | indication | 721301004 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
| Dissociation level | Dissociation constant | Type (acidic/basic) |
|---|---|---|
| pKa1 | 4.44 | 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 10131667 | April 17, 2034 | FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 10131667 | April 17, 2034 | FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 10131667 | April 17, 2034 | FOR THE TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT |
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING ONCE DAILY A TABLET CONTAINING ABOUT 0.5 MG TO ABOUT 10 MG OF PEMIGATINIB |
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB IN A DAILY DOSE OF ABOUT 5 MG TO ABOUT 20 MG |
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB QD FOR 14 DAYS THEN NOT ADMINISTERING PEMIGATINIB FOR 7 DAYS IN A 21-DAY CYCLE |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING ONCE DAILY A TABLET CONTAINING ABOUT 0.5 MG TO ABOUT 10 MG OF PEMIGATINIB |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB IN A DAILY DOSE OF ABOUT 5 MG TO ABOUT 20 MG |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB QD FOR 14 DAYS THEN NOT ADMINISTERING PEMIGATINIB FOR 7 DAYS IN A 21-DAY CYCLE |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING ONCE DAILY A TABLET CONTAINING ABOUT 0.5 MG TO ABOUT 10 MG OF PEMIGATINIB |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB IN A DAILY DOSE OF ABOUT 5 MG TO ABOUT 20 MG |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11466004 | May 3, 2039 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB QD FOR 14 DAYS THEN NOT ADMINISTERING PEMIGATINIB FOR 7 DAYS IN A 21-DAY CYCLE |
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INDUCERS |
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INHIBITORS |
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS WITH FGFR1 REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INDUCERS |
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS WITH FGFR1 REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INHIBITORS |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INDUCERS |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INHIBITORS |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS WITH FGFR1 REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INDUCERS |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS WITH FGFR1 REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INHIBITORS |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INDUCERS |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FGFR2 FUSION OR OTHER REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INHIBITORS |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS WITH FGFR1 REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INDUCERS |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | 11628162 | Aug. 30, 2040 | TREATMENT OF RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS WITH FGFR1 REARRANGEMENT BY ADMINISTERING PEMIGATINIB WHILE AVOIDING THE CONCOMITANT USE OF STRONG AND MODERATE CYP3A INHIBITORS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2027 | INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2027 | INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | April 17, 2027 | INDICATED FOR THE TREATMENT OF ADULTS WITH PREVIOUSLY TREATED, UNRESECTABLE LOCALLY ADVANCED OR METASTATIC CHOLANGIOCARCINOMA WITH A FIBROBLAST GROWTH FACTOR RECEPTOR 2 (FGFR2) FUSION OR OTHER REARRANGEMENT AS DETECTED BY AN FDA-APPROVED TEST |
| 13.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | Aug. 26, 2029 | TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT |
| 4.5MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | Aug. 26, 2029 | TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT |
| 9MG | PEMAZYRE | INCYTE CORP | N213736 | April 17, 2020 | RX | TABLET | ORAL | Aug. 26, 2029 | TREATMENT OF ADULTS WITH RELAPSED OR REFRACTORY MYELOID/LYMPHOID NEOPLASMS (MLNS) WITH FIBROBLAST GROWTH FACTOR RECEPTOR 1 (FGFR1) REARRANGEMENT |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Fibroblast growth factor receptor 3 | Kinase | INHIBITOR | IC50 | 9 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Fibroblast growth factor receptor 1 | Kinase | INHIBITOR | IC50 | 9.40 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Fibroblast growth factor receptor 2 | Kinase | INHIBITOR | IC50 | 9.30 | SCIENTIFIC LITERATURE | DRUG LABEL | |||
| Fibroblast growth factor receptor 4 | Kinase | INHIBITOR | IC50 | 7.52 | SCIENTIFIC LITERATURE |
External reference:
| ID | Source |
|---|---|
| Y6BX7BL23K | UNII |
| 4039347 | VANDF |
| C4724807 | UMLSCUI |
| CHEBI:757002 | CHEBI |
| 8ZF | PDB_CHEM_ID |
| CHEMBL4297522 | ChEMBL_ID |
| 86705695 | PUBCHEM_CID |
| DB15102 | DRUGBANK_ID |
| 10712 | INN_ID |
| C000705477 | MESH_SUPPLEMENTAL_RECORD_UI |
| D11417 | KEGG_DRUG |
| 9767 | IUPHAR_LIGAND_ID |
| 871699001 | SNOMEDCT_US |
| 871709004 | SNOMEDCT_US |
| 333127 | MMSL |
| 38333 | MMSL |
| d09543 | MMSL |
| 018334 | NDDF |
| 2359268 | RXNORM |
| Y6BX7BL23K | INXIGHT DRUGS |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| PEMAZYRE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50881-026 | TABLET | 4.50 mg | ORAL | NDA | 29 sections |
| PEMAZYRE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50881-027 | TABLET | 9 mg | ORAL | NDA | 29 sections |
| PEMAZYRE | HUMAN PRESCRIPTION DRUG LABEL | 1 | 50881-028 | TABLET | 13.50 mg | ORAL | NDA | 29 sections |