Accelerated FDA approval for Pomalyst in Kaposi sarcoma

16 May 2020

The US Food and Drug Administration on Friday expanded the indication of already-marketed Pomalyst (pomalidomide) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy and Kaposi sarcoma in adult patients who are HIV-negative.

Developed by Celgene, which is now part of Bristol-Myers Squibb (NYSE: BMY), Pomalyst becomes the first new treatment option for Kaposi sarcoma in more than 20 years. Under its existing indications, Pomalyst, first approved in February 2013 for advanced multiple myeloma, generated sales of $713 million for the company in the first-quarter of this year.

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), the FDA noted.

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