(Head and Neck Cancer) Nivolumab Drug Approval Information
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- July 28, 2016
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On July 27, Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb jointly announced the approval of a partial change in manufacturing/marketing authorization for patients with recurrent and metastatic head and neck cancer.
The approval was based on results from CheckMate-141 — a Phase 3 clinical trial enrolling patients with recurrent and metastatic squamous cell carcinoma of the head and neck (SCCHN) following platinum-based chemotherapy, comparing Opdivo (nivolumab) against investigator's choice chemotherapy.
Key Results
Based on overall survival (OS):
- Patients receiving Opdivo: 30% reduction in mortality risk
- Median OS with Opdivo: 7.5 months
- Median OS with investigator's choice chemotherapy: 5.1 months (HR: 0.70, p=0.0101)
- 1-year survival rate: Opdivo 36% vs. control group 16.6%
Based on these CheckMate-141 results, the trial was concluded early due to demonstrated efficacy. Additionally, on July 18, the US FDA and the European EMA both announced approval of Opdivo for SCCHN patients.
Tags: #HeadNeckCancer
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