US, EU regulators to review Opdivo for new cancer indication
- The Food and Drug Administration and the European Medicines Agency have accepted marketing applications from Bristol-Myers Squibb to expand the label for the company's PD-1 immune checkpoint inhibitor Opdivo to include treatment of advanced head and neck cancer.
- Head and neck cancer is a hard-to-treat disease with a 4% five-year survival rate in stage 4 patients. Findings from the Checkmate-141 trial have demonstrated an overall survival benefit in head and neck cancer patients after treatment with Opdivo.
- Both agencies have already approved Opdivo for treatment of melanoma, lung and renal cancer in the U.S. and the EU. The FDA also recently approved Opdivo to treat classical Hodgkin lymphoma, and has set its action date for the new indication as November 11, 2016.
All signs point towards a favorable outcome for Bristol-Myers when the U.S. and EU regulators make their decisions. In April, the FDA tagged Opdivo with a breakthrough therapy designation and priority review for treatment of metastatic squamous cell carcinoma of the head and neck (SCCHN), and the EMA has already moved into regulatory review.
In addition, an independent monitoring committee stopped the Checkmate-141 trial early when it met its primary endpoint (increasing overall survival) in January. The study results showed treatment with Opdivo reduced patient risk of death by 30%; improved median overall survival to 7.5 months versus other drugs' 5.1 months; and more than doubled one-year survival rates to 36%, compared with the control group's 17%.
Both Opdivo and its main competitor Keytruda, manufactured by Merck, have been racking up the approvals. But Bristol-Myers' Opdivo leads the field with sales of $704 million in Q1 2016, versus Keytruda's $254 million.
Bristol-Myers does not appear to be stopping its expansion anytime soon: less than a month ago, the company snagged a sixth breakthrough therapy designation for bladder cancer. Analysts estimate the drug could reach $11.1 billion in annual sales by 2020, Reuters reports.
- Bristol-Myers Squibb Statement