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Opdivo approved for non-squamous NSCLC

October 10, 2015 1:32 AM UTC

FDA approved Opdivo nivolumab from Bristol-Myers Squibb Co. (NYSE:BMY) to treat metastatic non-squamous non-small cell lung cancer (NSCLC) in patients who have progressed on or after platinum-based chemotherapy, well ahead of its Jan. 2, 2016, PDUFA date. The PD-1 inhibitor is already approved to treat metastatic squamous NSCLC.

The drug's label does not limit its use based on PD-L1 expression levels, although FDA said it appears that higher expression of PD-L1 "predicts those most likely to benefit" from Opdivo. ...