selinexor 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definition	Drug id	CAS RN
nuclear export inhibitors	5330	1393477-72-9

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: selinexor xpovio KPT-330	Selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins by blocking exportin 1(XPO1) Molecular weight: 443.31 Formula: C17H11F6N7O CLOGP: 2.96 LIPINSKI: 0 HAC: 8 HDO: 2 TPSA: 97.62 ALOGS: -4.90 ROTB: 7 Status: ONP Legend: OFP - off patent OFM - off market ONP - on patent

Molecule

Description

Molfile Inchi Smiles

Synonyms:

selinexor
xpovio
KPT-330

Selinexor reversibly inhibits nuclear export of tumor suppressor proteins (TSPs), growth regulators, and mRNAs of oncogenic proteins by blocking exportin 1(XPO1)

Molecular weight: 443.31
Formula: C17H11F6N7O
CLOGP: 2.96
LIPINSKI: 0
HAC: 8
HDO: 2
TPSA: 97.62
ALOGS: -4.90
ROTB: 7

Status: ONP

Legend:
OFP - off patent
OFM - off market
ONP - on patent

Drug dosage:

None

ADMET properties:

Property	Value	Reference
S (Water solubility)	0.03 mg/mL	Bocci G, Oprea TI, Benet LZ
BDDCS (Biopharmaceutical Drug Disposition Classification System)	2	Bocci G, Oprea TI, Benet LZ

Approvals:

Date	Agency	Company	Orphan
March 26, 2021	EMA	Karyopharm Europe GmbH
July 3, 2019	FDA	KARYOPHARM THERAPEUTICS INC

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
Thrombocytopenia	374.27	52.96	133	1193	151024	63336672
Nausea	148.87	52.96	129	1197	854342	62633354
Neutropenia	72.28	52.96	45	1281	174960	63312736
Vomiting	62.86	52.96	67	1259	559550	62928146
Diffuse large B-cell lymphoma refractory	55.73	52.96	11	1315	1219	63486477

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
Thrombocytopenia	250.91	45.96	128	1500	156119	34799184
Nausea	155.05	45.96	126	1502	339782	34615521
Plasma cell myeloma refractory	91.68	45.96	17	1611	598	34954705
Diffuse large B-cell lymphoma refractory	90.90	45.96	19	1609	1247	34954056
Decreased appetite	75.60	45.96	62	1566	166330	34788973
Pneumonia	64.18	45.96	81	1547	362546	34592757
Fatigue	62.76	45.96	81	1547	370572	34584731
Hyponatraemia	57.88	45.96	40	1588	82651	34872652
Disease progression	56.90	45.96	44	1584	108033	34847270

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
Thrombocytopenia	605.89	47.44	258	2694	265001	79476435
Nausea	265.88	47.44	242	2710	956954	78784482
Diffuse large B-cell lymphoma refractory	141.41	47.44	27	2925	1408	79740028
Decreased appetite	124.75	47.44	102	2850	342316	79399120
Pneumonia	108.55	47.44	127	2825	660119	79081317
Hyponatraemia	91.00	47.44	65	2887	177783	79563653
Disease progression	88.90	47.44	65	2887	184297	79557139
Neutropenia	84.73	47.44	76	2876	287634	79453802
Fatigue	81.51	47.44	132	2820	929595	78811841
Febrile neutropenia	69.87	47.44	62	2890	230937	79510499
Anaemia	68.45	47.44	83	2869	444932	79296504
Vomiting	64.25	47.44	99	2853	665729	79075707
Platelet count decreased	58.32	47.44	52	2900	194612	79546824

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	L01XX66	ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS ANTINEOPLASTIC AGENTS OTHER ANTINEOPLASTIC AGENTS Other antineoplastic agents
FDA EPC	N0000194021	Nuclear Export Inhibitor
FDA MoA	N0000194022	Nuclear Export Inhibitors

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Relapse multiple myeloma	indication	452291000124109

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation level	Dissociation constant	Type (acidic/basic)
pKa1	9.3	acidic
pKa2	2.61	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
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	10544108	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	10544108	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	11034660	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	11034660	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10544108	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10544108	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	11034660	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	11034660	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10544108	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10544108	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	11034660	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	11034660	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10544108	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10544108	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	11034660	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	11034660	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	9079865	July 26, 2032	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED IN COMBINATION WITH BORTEZOMIB AND DEXAMETHASONE FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	10519139	Aug. 14, 2035	XPOVIO IS INDICATED IN COMBINATION WITH DEXAMETHASONE TO TREAT RELAPSED OR REFRACTORY MULTIPLE MYELOMA (REFRACTORY TO AT LEAST AN ANTI-CD38 MAB, 2 PROTEASOME INHIBITORS AND 2 IMMUNOMODULATORY AGENTS) IN ADULTS WHO RECEIVED AT LEAST 4 PRIOR THERAPIES

Orange Book exclusivity data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	June 22, 2023	TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	July 3, 2024	NEW CHEMICAL ENTITY
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	July 3, 2026	IN COMBO W/ DEXAMETHASONE FOR ADULTS W/ RELAPSED OR REFRACTORY MULTIPLE MYELOMA WHO RECEIVED AT LEAST 4 PRIOR THERAPIES AND REFRACTORY TO AT LEAST 2 PROTEASOME INHIBITORS, AT LEAST 2 IMMUNOMODULATORY AGENTS, AND AN ANTI-CD38 MONOCLONAL ANTIBODY
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	July 3, 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)
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	July 3, 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)
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	July 3, 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)
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	June 22, 2027	INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH RELAPSED OR REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL), NOT OTHERWISE SPECIFIED, INCLUDING DLBCL ARISING FROM FOLLICULAR LYMPHOMA, AFTER AT LEAST 2 LINES OF SYSTEMIC THERAPY
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	June 22, 2027	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)
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	June 22, 2027	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)
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	June 22, 2027	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)
20MG	XPOVIO	KARYOPHARM THERAPS	N212306	July 3, 2019	RX	TABLET	ORAL	Dec. 18, 2027	FOR THE TREATMENT OF ADULT PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY, EXCLUDING ADULT PATIENTS COVERED BY XPOVIOS PREVIOUS INDICATION FOR MULTIPLE MYELOMA APPROVED ON JULY 3, 2019
40MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	Dec. 18, 2027	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)
50MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	Dec. 18, 2027	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)
60MG	XPOVIO	KARYOPHARM THERAPS	N212306	April 15, 2021	RX	TABLET	ORAL	Dec. 18, 2027	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
Exportin-1	Nuclear other	O14980	XPO1_HUMAN	INHIBITOR	IC50	7.70		SCIENTIFIC LITERATURE	DRUG LABEL

External reference:

ID	Source
31TZ62FO8F	UNII
C3852671	UMLSCUI
CHEMBL3545185	ChEMBL_ID
71481097	PUBCHEM_CID
DB11942	DRUGBANK_ID
D11222	KEGG_DRUG
9872	INN_ID
10036	IUPHAR_LIGAND_ID
018055	NDDF
788703001	SNOMEDCT_US
788710007	SNOMEDCT_US
4038565	VANDF
2178390	RXNORM
319363	MMSL
37137	MMSL
d09321	MMSL
C585161	MESH_SUPPLEMENTAL_RECORD_UI

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-101	TABLET, FILM COATED	20 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-101	TABLET, FILM COATED	20 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-101	TABLET, FILM COATED	20 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-102	TABLET, FILM COATED	40 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-102	TABLET, FILM COATED	40 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-102	TABLET, FILM COATED	40 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-103	TABLET, FILM COATED	50 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-103	TABLET, FILM COATED	50 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-103	TABLET, FILM COATED	50 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-104	TABLET, FILM COATED	60 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-104	TABLET, FILM COATED	60 mg	ORAL	NDA	26 sections
XPOVIO	HUMAN PRESCRIPTION DRUG LABEL	1	72237-104	TABLET, FILM COATED	60 mg	ORAL	NDA	26 sections