'Breakthrough' designation for Pomalyst in HIV-positive and negative Kaposi sarcoma

The US Food and Drug Administration 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.

Pomalyst is already a major product for US biotech Celgene (Nasdaq: CELG), generating sales of $2 billion in full-year 2018, an increase of 26% year-over-year.

Celgene, which is the subject of a $74 billion share and cash acquisition by US pharma major Bristol-Myers Squibb (NYSE: BMS), plans to submit a supplemental New Drug Application for Pomalyst in this disease area by the end of 2019. With its breakthrough status, the drug will receive accelerated review by the FDA, which approved the thalidomide analogue in February 2013 for advanced multiple myeloma.