FDA Grants Accelerated Approval to Pomalidomide for Karposi Sarcoma

On May 14, 2020, the U.S. Food and Drug Administration (FDA) expanded the indication of pomalidomide (Pomalyst) to include treating adult patients with AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy (HAART) and Kaposi sarcoma in adult patients 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).

Read the FDA announcement.

Posted 5/15/2020