Breakthrough therapy designation for Pomalyst to treat (HIV)-positive Kaposi sarcoma

Celgene Corporation announced that the FDA has granted Breakthrough Therapy designation to Pomalyst (pomalidomide) for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi sarcoma who have previously received systemic chemotherapy, as well as patients with HIV-negative Kaposi’s sarcoma.

The Breakthrough Therapy designation was granted by the FDA on the basis of the results of a clinical study performed under a Cooperative Research and Development Agreement (CRADA) by a team led by Dr. Robert Yarchoan, of the HIV and AIDS Malignancy Branch within the Center for Cancer Research of the National Cancer Institutes (NCI). The results of that study evaluated Pomalyst in patients with Kaposi sarcoma, with or without HIV infection, many of whom had received prior cytotoxic chemotherapy.

Celgene also has two additional studies planned in this disease. In partnership with the AIDS Malignancy Consortium (AMC), a U.S. multicenter study will be performed to confirm and extend the results of the NCI study. The AMC is also sponsoring a second study in sub-Saharan Africa, where Kaposi sarcoma continues to be a serious problem. This program is a part of the Celgene Global Health effort to discover and develop new drugs for diseases that affect patients in the lower- and middle-income countries where health systems and medical resources are less advanced.

See-Journal of Clinical Oncology (MN Polizzotto et al, JCO, 2016, 34, 4125-31).

Celgene plans to submit a supplemental New Drug Application for Pomalyst in this disease area by the end of 2019.