Bristol-Myers Squibb Cancer Drug Receives Expedited FDA Status
Bristol-Myers Squibb Company said early Monday that the Food and Drug Administration would expedite the development and review of its head and neck cancer drug Opdivo on the strength of its phase 3 trial results. Opdivo, which received the special status for the potential indication of recurrent or metastatic squamous cell carcinoma of the head and neck after therapy, also previously got the designation for the purposes of Hodgkin lymphoma, previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer and advanced or metastatic renal cell carcinoma. According to Bristol-Myers Squibb, nearly all of head-and-neck cancers are classified as squamous cell carcinoma. The company's stock was up 0.5% in pre-market trade.
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