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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

DateArticle
May 15, 2020Approval  U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Pomalyst (pomalidomide) for AIDS-Related and HIV-Negative Kaposi Sarcoma
Feb  8, 2013Approval  FDA Approves Pomalyst for Advanced Multiple Myeloma
Oct  3, 2012Celgene Corporation Provides Update on FDA Advisory Committee for Pomalidomide
Apr 27, 2012The International Myeloma Foundation Says Pomalidomide, an Important New Drug for Patients, Has Been Submitted for FDA Approval

Further information

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