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Stock Market & Financial Investment News

News Breaks
June 3, 2014
09:00 EDTCLVSClovis falls 11.9%
Clovis is down 11.9%, or $5.68, to $42.07
News For CLVS From The Last 14 Days
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February 12, 2016
08:59 EDTCLVSClovis says FDA schedules rociletinib NDA for discussion by ODAC on April 12
Clovis Oncology said that the U.S. FDA has scheduled the New Drug Application for rociletinib for discussion by the Oncologic Drugs Advisory Committee, or ODAC, on April 12, 2016. Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation. The ODAC reviews and evaluates data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer and makes recommendations to the FDA. "We are actively preparing for this advisory committee meeting and look forward to the discussion about rociletinib," said Patrick J. Mahaffy, President and CEO of Clovis Oncology. "New treatments are needed for this hard-to-treat patient population, and we believe that rociletinib represents an important new option for patients with mutant EGFR T790M-positive lung cancer."

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