Posted by Michael Wonder on 15 May 2020
U.S. Food and Drug Administration approves Bristol Myers Squibb’s Pomalyst (pomalidomide) for AIDS-related and HIV-negative Kaposi sarcoma
15 May 2020 - Pomalyst is the only oral and first new treatment option for Kaposi sarcoma in more than 20 years.
Bristol Myers Squibb today announced that 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 (HAART), or in patients with Kaposi sarcoma who are HIV-negative. Patients with AIDS-related Kaposi sarcoma should continue HAART for their HIV as recommended by their physician.
Pomalyst was granted accelerated approval, Breakthrough Therapy designation and Orphan Drug designation in these indications based on overall response rates observed in a Phase 1/2 open label, single-arm clinical trial (12-C-0047).
