- Bristol-Myer Squibb's cancer drug Opdivo won accelerated approval from the FDA on Tuesday for treatment of classical Hodgkin lymphoma (cHL), further bolstering its leading position in the immuno-oncology market.
- Opdivo was evaluated in two single-arm trials among patients with relapsed, refractory cHL. In the study evaluating efficacy, treatment with Opdivo led to a 65% objective response rate and induced complete cancer remission in 7% of patients.
- The FDA noted continued approval in this indication could be contingent upon establishing clinical benefit through a randomized phase 3 trial.
Opdivo and Merck's Keytruda are the first anti-PDL1 checkpoint inhibitors approved for the U.S. market. Both have demonstrated promising, and at times dramatic, clinical efficacy in checking cancer growth. Although Keytruda was approved first, Opdivo has racked up more indications and outpaced Keytruda in sales.
In the first quarter, Opdivo pulled in $704 million in sales (mostly in the U.S.), markedly higher than the $249 million earned by Keytruda. Both Bristol-Myers and Merck are pursuing other indications, most recently in carcinoma of the head and neck.
This newest approval from the FDA was granted on the strength of Opdivo's efficacy and safety data from two single-arm trials. Among cHL patients previously treated with autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin, Opdivo produced a 65% objective response rate overall. Nearly three-fifths of the 95 patients experienced partial remission and 7% saw compete remission of their cancer.
Serious adverse reactions, such as pneumonia or pleural effusion, were reported in 21% of patients participating in the separate safety study, however.
The FDA will require Opdivo's label to be updated with a new "Warning and Precaution" detailing risk for complications of allogeneic HSCT after treatment with Opdivo.
Opdivo's approval for this indication came well ahead of its target PDUFA date of September 1, 2016.