Bristol Myers’ Pomalyst Approved by FDA for Kaposi Sarcoma

Bristol Myers says Pomalyst (pomalidomide) was approved by the U.S. FDA for patients with AIDS-related Kaposi sarcoma whose disease has become resistant to highly active antiretroviral therapy, or in patients who are HIV-negative.

• Pomalyst was granted accelerated approval, Breakthrough Therapy designation and Orphan Drug designation in these indications based on a Phase 1/2 open label, single-arm clinical trial
• Continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial
• Pomalyst is the only oral and first new treatment option for Kaposi sarcoma in more than 20 years

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