US regulators are undertaking a priority review of Bristol-Myers Squibb’s immunotherapy Opdivo for the treatment of patients with advanced renal cell carcinoma, the most common form of kidney cancer which kills more than 100,000 people every year.
The company is seeking to expand the drug’s scope - adding to its skin and lung cancer indications - to include RCC patients who have received prior anti-angiogenic therapy. The FDA is expected to make a decision by March 16.
Opdivo (nivolumab) already carries a Breakthrough Therapy Designation for RCC indication, which BMS says underscores the “critical need” for new treatment options for this patient group.
The drug’s supplemental filing is centred on findings from the Checkmate-025 trial, which assessed Opdivo versus Novartis’ Afinitor (everolimus), the current standard of care, in previously treated advanced or metastatic clear-cell renal cell carcinoma.
The trial was stopped early in July after an analysis showed that Opdivo significantly improved overall survival compared to Afinitor, marking the first time an immunotherapy was shown to offer a survival advantage for this group of patients, whose treatment options remain limited.