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Clovis Oncology Issues Update On Rociletinib, Will Meet With FDA On April 12


Clovis Oncology Inc (NASDAQ: CLVS) announced on Friday that the U.S. Food and Drug Administration has scheduled a date of April 12, 2016 to discuss a New Drug Application for its rociletinib therapy.

Rociletinib is an investigational therapy for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC).

Clovis Oncology will meet with Oncologic Drugs Advisory Committee which reviews and evaluates data concerning the safety and effectiveness of marketed and 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."

Shares of Clovis were trading lower by more than 3 percent on Friday following the company's announcement.


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Posted-In: Cancer Therapies lung cancer Patrick Mahaffy rociletinibNews FDA

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