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 centered 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.
No comments:
Post a Comment