The Food and Drug Administration has granted a priority review for expanded use of nivolumab for patients with previously treated recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), based on results of Checkmate-141.
CheckMate-141 was stopped early in January 2016 after the study met its primary endpoint of improved overall survival in SCCHN patients receiving nivolumab after platinum-based therapy, compared to investigator’s choice of therapy (methotrexate, docetaxel, or cetuximab).
The FDA is expected to act on the review by Nov. 11, 2016, according to a written statement from Bristol-Myers Squib, makers of nivolumab.
The PD-1 immune checkpoint inhibitor, marketed as Opdivo, was also granted breakthrough therapy designation by the FDA for the treatment of unresectable locally advanced or metastatic urothelial carcinoma that has progressed during or following a platinum-based regimen, according to another written statement from Bristol-Myers Squibb. This is the sixth breakthrough therapy designation for nivolumab.
The breakthrough therapy designation in bladder cancer is based on the results of the phase II CA209-275 trial and other supportive data.
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