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Rociletinib Approval Status

Rociletinib is a mutant-selective inhibitor of epidermal growth factor receptor (EGFR) in development for the treatment of metastatic EGFR T790M-mutant non–small cell lung cancer (NSCLC).

In May 2016, Clovis Oncology, Inc. announced it has terminated enrollment in all ongoing sponsored studies of rociletinib, including TIGER-3, after the company was notified at meeting with the FDA that it could anticipate receiving a Complete Response Letter (CRL) for the rociletinib NDA on or before the PDUFA date of June 28, 2016. Clovis has also withdrawn its Marketing Authorization Application of rociletinib with European regulatory authorities.

Development Status and FDA Approval Process for rociletinib

May  5, 2016Clovis Oncology Terminates Enrollment in all Ongoing Sponsored Clinical Studies of Rociletinib
Apr 12, 2016Clovis Oncology Provides Update on FDA Oncologic Drugs Advisory Committee Meeting to Review Rociletinib
Dec 15, 2015Clovis Oncology Receives Notification of PDUFA Extension for Rociletinib
Nov 16, 2015Clovis Oncology Announces Regulatory Update for Rociletinib NDA Filing
Nov 15, 2015Clovis Oncology Announces U.S. and E.U. Regulatory Milestones for Rociletinib in the Treatment of Advanced EGFR-Mutant T790M+ Non-Small Cell Lung Cancer
Aug  3, 2015Clovis Oncology Submits NDA for Rociletinib for the Treatment of Advanced EGFR-Mutant T790M+ Non-small Cell Lung Cancer
Jul  1, 2015Clovis Oncology Initiates Rolling NDA Submission for Rociletinib in Advanced EGFR-Mutant Non-Small Cell Lung Cancer

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