Pomalyst Receives New Indication for Kaposi Sarcoma

May 15, 2020 – The U.S. FDA has approved a new indication for Pomalyst® (pomalidomide), manufactured by Bristol Myers Squibb. It is indicated to treat AIDS-related Kaposi sarcoma (KS) after failure of highly active antiretroviral therapy (HAART) or to treat patients with KS who are HIV negative.

Kaposi sarcoma is a rare cancer caused by human herpesvirus-8 and is most often diagnosed in individuals infected with HIV who are immunocompromised. An estimated six out of every one million people in the United States will be diagnosed with the disease in a given year. It most often manifests as skin lesions but can also occur in other parts of the body, such as the lungs, lymph nodes, and digestive system.

In a clinical study, Pomalyst delivered an overall response rate of 71%. Of patients who responded to treatment, 14% had a complete response while 57% achieved a partial response. Half of patients had a duration of response lasting 12 months or more. The study included both HIV-positive and HIV-negative KS patients, the majority of whom had advanced disease.

Recommended dosing under the new indication is 5mg taken by mouth once a day on Days 1 through 21 of repeated 28-day cycles until disease progression or unacceptable toxicity. Dosage may need to be adjusted for patients who have renal or hepatic impairment.

A black box warning cautions that Pomalyst carries a risk of embryo-fetal toxicity, as well as venous and arterial thromboembolism. The FDA granted accelerated approval for the new KS indication, meaning continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.

Originally FDA approved in 2013, Pomalyst is also indicated for use in combination with dexamethasone to treat multiple myeloma in patients who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.