FDA Grants Opdivo New Breakthrough Therapy Status
Bristol-Myers Squibb announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo (nivolumab), to potentially treat recurrent or metastic squamous cell carcinoma of the head and neck (SCCHN) after platinum based therapy. This is the fifth Breakthrough status the FDA has granted Opdivo.
The new designation is supported by the ‘CheckMate -141' Phase 3, open-label, randomized trial. The trial evaluated Opdivo vs. investigator's choice of therapy in patients with recurrent or metastatic SCCHN with tumor progression within 6 months of platinum therapies in the adjuvant, primary, recurrent or metastatic setting.
The Independent Data Monitoring Committee (DMC) halted the CheckMate trial in early January 2016, after adjudging that the study met its primary endpoint of overall survival.
Opdivo, a PD-1 immune checkpoint inhibitor, is currently indicated to treat BRAF V600 wild-type unresectable or metastatic melanoma; metastatic non-small cell lung cancer (NSCLC); and advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.
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