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CHMP Positive Opinions of Opdivo Recommend it Expand Existing Indication to Include Previously Treated Metastatic Non-squamous Non-small Cell Lung Cancer and Advanced Renal Cell Carcinoma

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Additional Information

Additional Relevant Details Bristol-Myers Squibb received two positive CHMP opinions for Opdivo (nivolumab) for adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapy, and adults with advanced renal cell carcinoma (RCC) after prior therapy.  Both indications are supported by Phase 3 studies in which Opdivo demonstrated a survival benefit versus a standard of care.  The EC now reviews Opdivo for approval of these new indications
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Occurred on:
Feb 26, 2016
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Related Keywords Chmp, Positive Opinion, Metastatic Non-small Cell Lung Cancer, Advanced Or Metastatic Renal Cell Carcinoma, Opdivo, Nivolumab