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

Stem definitionDrug idCAS RN
5330 1393477-72-9

Description:

MoleculeDescription

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:

None

Approvals:

DateAgencyCompanyOrphan
March 26, 2021 EMA Karyopharm Europe GmbH
July 3, 2019 FDA KARYOPHARM THERAPEUTICS INC

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Thrombocytopenia 259.62 54.60 91 736 127582 50476715
Nausea 103.97 54.60 87 740 705311 49898986
Vomiting 55.26 54.60 51 776 460707 50143590

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Thrombocytopenia 216.26 47.57 103 1014 134720 29438690
Nausea 120.21 47.57 93 1024 289162 29284248
Diffuse large B-cell lymphoma refractory 70.07 47.57 14 1103 908 29572502
Fatigue 58.26 47.57 65 1052 316756 29256654
Hyponatraemia 51.84 47.57 32 1085 67601 29505809
Decreased appetite 51.64 47.57 43 1074 145299 29428111

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Thrombocytopenia 459.06 45.82 190 1763 223611 64273168
Nausea 195.81 45.82 171 1782 785629 63711150
Diffuse large B-cell lymphoma refractory 127.04 45.82 23 1930 1101 64495678
Decreased appetite 91.25 45.82 72 1881 281217 64215562
Hyponatraemia 73.09 45.82 49 1904 148290 64348489
Neutropenia 66.31 45.82 56 1897 239568 64257211
Fatigue 65.16 45.82 95 1858 748635 63748144
Pneumonia 62.15 45.82 80 1873 559496 63937283
Vomiting 55.29 45.82 75 1878 551042 63945737
Anaemia 53.06 45.82 61 1892 378619 64118160
Febrile neutropenia 48.04 45.82 42 1911 187615 64309164

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
ATC L01XX66 ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
ANTINEOPLASTIC AGENTS
OTHER ANTINEOPLASTIC AGENTS
Other antineoplastic agents

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Relapse multiple myeloma indication 452291000124109




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

Dissociation levelDissociation constantType (acidic/basic)
pKa1 9.3 acidic
pKa2 2.61 Basic

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent 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 strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
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:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Exportin-1 Nuclear other INHIBITOR IC50 7.70 SCIENTIFIC LITERATURE DRUG LABEL

External reference:

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

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
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 72237-103 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