Pomalyst FDA Approval History
Last updated by Judith Stewart, BPharm on March 16, 2021.
FDA Approved: Yes (First approved February 8, 2013)
Brand name: Pomalyst
Generic name: pomalidomide
Dosage form: Capsules
Company: Bristol-Myers Squibb Company
Treatment for: Multiple Myeloma, Kaposi's Sarcoma
Pomalyst (pomalidomide) is a thalidomide analogue used for the treatment of multiple myeloma, and AIDS-related and HIV-negative Kaposi sarcoma.
Pomalyst is 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.
- 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).
Development Timeline for Pomalyst
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