The FDA designates Celgene's (NASDAQ:CELG) POMALYST (pomalidomide) a Breakthrough Therapy for the treatment of patients with human immunodeficiency virus (HIV)-positive Kaposi's sarcoma (KS) who have previously received systemic chemotherapy, as well as patients with HIV‐negative KS.
KS is a rare type of cancer characterized by purplish lesions on the skin that can occur in immunocompromised patients, including those with HIV infections.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
The FDA approved the thalidomide analogue in February 2013 for advanced multiple myeloma.
Subscribe for full text news in your inbox