Pomalyst

Product manufactured by Celgene Corporation

Application Nr Approved Date Route Status External Links
NDA204026 None Oral None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Pomalyst Is A Thalidomide Analogue Indicated, For The Treatment Of Adult Patients: In Combination With Dexamethasone, For Patients With Multiple Myeloma (Mm) Who Have Received At Least Two Prior Therapies Including Lenalidomide And A Proteasome Inhibitor And Have Demonstrated Disease Progression On Or Within 60 Days Of Completion Of The Last Therapy ( 1.1 ). With Aids-Related Kaposi Sarcoma (Ks) After Failure Of Highly Active Antiretroviral Therapy (Haart) Or In Patients With Ks Who Are Hiv-Negative. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate. Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S) ( 1.2 ). 1.1 Multiple Myeloma Pomalyst, In Combination With Dexamethasone, Is Indicated For Adult Patients With Multiple Myeloma (Mm) Who Have Received At Least Two Prior Therapies Including Lenalidomide And A Proteasome Inhibitor And Have Demonstrated Disease Progression On Or Within 60 Days Of Completion Of The Last Therapy. 1.2 Kaposi Sarcoma Pomalyst Is Indicated For The Treatment Of: Adult Patients With Aids-Related Kaposi Sarcoma (Ks) After Failure Of Highly Active Antiretroviral Therapy (Haart). Kaposi Sarcoma (Ks) In Adult Patients Who Are Hiv-Negative. This Indication Is Approved Under Accelerated Approval Based On Overall Response Rate [See Clinical Studies (14.2) ] . Continued Approval For This Indication May Be Contingent Upon Verification And Description Of Clinical Benefit In A Confirmatory Trial(S).

All Formulated Excipients (0 Total)

None

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Pomalidomide POMALIDOMIDE ZINC1997125

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