New Treatment for Kaposi Sarcoma

The FDA has expanded the use of an immunomodulatory therapeutic to include the treatment of adults who have Kaposi sarcoma.

The U.S. Food and Drug Administration (FDA) has expanded the use of an immunomodulatory therapeutic called pomalidomide (Pomalyst) to include the treatment of adults who have Kaposi sarcoma.

Kaposi sarcoma is a rare type of cancer that arises in the skin; the mucous membranes lining the mouth, nose, and throat; lymph nodes; or other organs. Cancers often arise in more than one place in the body at the same time. They are associated with human herpesvirus-8, also known as Kaposi sarcoma herpesvirus.

There are several types of Kaposi sarcoma. The most common type of the cancer in the United States is epidemic Kaposi sarcoma, also known as AIDS-related Kaposi sarcoma. Treating patients who have HIV with highly active antiretroviral therapy (HAART) frequently keeps Kaposi sarcoma at bay. 

Another type of Kaposi sarcoma diagnosed in the United States is classic Kaposi sarcoma. This type of the disease is most commonly detected in older men of Italian or Eastern European Jewish origin.

Pomalidomide is intended for use in treating adults who have AIDS-related Kaposi sarcoma after failure of HAART and Kaposi sarcoma in adult patients who are HIV-negative.

Pomalidomide works against cancer by modulating aspects of the immune system and by reducing the production of molecules called VEGFs, which leads to disruption of new blood and lymphatic vessel networks. It was first approved by the FDA for treating multiple myeloma in February 2013. 

The approval of pomalidomide for treating patients who have Kaposi sarcoma was based on results from the phase I/II Study 12-C-0047 clinical trial conducted by the National Cancer Institute. According to the FDA statement, 12 of the 18 HIV-positive patients had partial or complete tumor shrinkage, and the responses lasted a median of 12.5 months. Eight of the 10 HIV-negative patients had partial or complete tumor shrinkage, and the responses lasted a median of 10.5 months.

The FDA approval was rendered on May 15, 2020.