Opdivo from BMS Wins Another US Approval

24.05.2016 -

The US Food and Drug Administration (FDA) has approved Bristol-Myers Squibb’s (BMS) cancer drug, Opdivo, to treat classical Hodgkin Lymphoma (HL). The approval is the eighth for Opdivo in less than two years, and the first for a PD-1 immunotherapy in a hematological cancer. HL is a rare cancer that affects the body’s lymphatic system and classical HL accounts for 95% of cases.

This latest accelerated approval is based on Phase 1 and 2 trials and is indicated for treating patients with classical HL who have relapsed or progressed after autologous haematopoietic stem cell transplantation and post-transplantation brentuximab vedotin. Continued approval may depend on verification of clinical benefit in confirmatory trials.

Opdivo is emerging as the dominant product in the PD-1 market, ahead of rival drug Keytruda from Merck. In the first quarter of 2016, sales of Opdivo were $704 million (mostly in the US), compared with sales of $249 million in the same period for Keytruda.

BMS’ other new hematological cancer treatment, Empliciti, which is co-marketed with AbbVie, received approvals from the US and European authorities last November and this month, respectively.