Bristol-Myers Squibb Co.'s surprise announcement that its Phase III CheckMate 227 first-line lung cancer study succeeded, but in a subset analysis that had not been prospectively defined, left one burning question – does the company have enough to file for approval? Management suggests the answer is yes, but some leading analysts have doubts.
Bristol's Opdivo/Yervoy Bid Will Show Whether Tumor Mutation Burden Is Ready For Prime Time
US FDA officials have supported tumor mutation burden as a biomarker, but analysts question whether a subset analysis of CheckMate 227 will be enough to support approval of Bristol's Opdivo/Yervoy combination in first-line lung cancer.
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