FDA Accepts Bristol-Myers Squibb Co Supplemental Yervoy BLA For Melanoma

March 4, 2015 8:01 PM

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Bristol-Myers Squibb Co (NYSE:BMY) stock soared over 2% yesterday after the company announced that the US Food and Drug Administration (FDA) had accepted for filing and review its supplemental Biologics License Application (sBLA) for its melanoma treatment drug, Yervoy. The company stated in its press release that it expects the FDA to announce a decision on the application on October 28, 2015.

The drug was earlier approved in March 2011 for the treatment of metastatic or unresectable melanoma in adults. The recent acceptance by the FDA of Yervoy’s sBLA is based on the results from a double-blinded and randomized late-stage clinical trial, CA184-029 (EORTC 18071), conducted to evaluate the...

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