Celgene has secured Breakthrough Therapy designation for Pomalyst (pomalidomide) for treating patients with HIV-positive and negative Kaposi sarcoma in the US.
Kaposi sarcoma is a multicentric tumour caused by Kaposi sarcoma-associated herpesvirus – also called human herpesvirus-8.
“The encouraging news of the FDA Breakthrough Therapy designation for Pomalyst in Kaposi sarcoma reflects the urgency in accelerating the development of therapies to address diseases of this type,” said Jay Backstrom, M.D., Chief Medical Officer for Celgene.
“We will continue to work closely with the agency to move this program forward for patients with this rare and serious cancer.”
The 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 Centre for Cancer Research of the National Cancer Institutes (NCI).
The results, published in the Journal of Clinical Oncology, evaluated Pomalyst in patients with Kaposi sarcoma, with or without HIV infection, many of whom had received prior cytotoxic chemotherapy.
Celgene said it plans to submit a supplemental New Drug Application for Pomalyst in this disease area by the end of 2019.
Presently, Pomalyst is not approved for Kaposi sarcoma in any country.