The U.S. Food and Drug Administration (FDA) has approved Pomalyst (pomalidomide) for treating patients Kaposi sarcoma, a rare skin cancer sometimes seen in people with AIDS or other immunocompromised conditions. More specifically, the drug is indicated to treat persons 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.

Pomalidomide was granted accelerated approval largely based on overall response rates observed in a Phase 1/2 open label, single-arm clinical trial. Continued approval will likely be contingent upon continuing positive results in a confirmatory trial.

In the Phase 1/2 study, 28 patients with Kaposi sarcoma (18 HIV-positive, 10 HIV-negative) received pomalidomide (5 mg once daily for 21 of 28-day cycles) until disease progression or unacceptable toxicity. All HIV-positive patients continued concomitant highly active antiretroviral therapy (HAART).The primary endpoint of the study was overall response rate (ORR). For all patients, the ORR was 71% (95% CI: 51, 87) with 14% (4/28) of patients achieving complete response. The median duration of re sponse for all patients was 12.1 months and 50% of patients who responded maintained a response for more than 12 months.

The most common adverse reactions were decreased absolute neutrophil count or white blood cells, elevated creatinine or glucose, rash, constipation, fatigue, decreased hemoglobin, platelets, phosphate. The drug comes with a boxed warning about embryo-fetal toxicity , as well as venous and arterial thromboembolism.

Kaposi sarcoma is a rare form of cancer that usually presents as skin lesions, but can develop in the lungs, lymph nodes and digestive system. The rare cancer is caused by Kaposi sarcoma-associated herpesvirus, also called human herpesvirus-8, and most commonly arises in persons infected with HIV who are immunocompromised.

To learn more about this and other rare cancers, visit


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