Pomalidomide for Kaposi sarcoma

June 10, 2020 0 By FM

Pomalidomide (Pomalyst) has been granted approval by the US 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. 

Pomalidomide 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).

The approval of pomalidomide was based on the findings of a phase 1/2 open-label, single-arm study conducted evaluating the safety, pharmacokinetics and efficacy of pomalidomide in patients with HIV-positive and HIV-negative symptomatic Kaposi sarcoma, the majority of whom had advanced disease.