The FDA granted accelerated approval to Bristol Myers Squibb’s Pomalyst (pomalidomide) for patients with AIDS-related or HIV-negative Kaposi sarcoma.
The agency approved the drug based on the results of a phase 1/2 clinical trial in which the drug demonstrated an overall response rate of 71 percent. Half of the participants maintained a response beyond 12 months.
Polymast is the first new treatment for Kaposi sarcoma in more than 20 years, and it is the only oral treatment. The drug received breakthrough therapy and orphan drug designations from the FDA.