Rociletinib Approval Status
FDA Approved: No
Generic name: rociletinib
Company: Clovis Oncology, Inc.
Treatment for: Non-Small Cell Lung Cancer
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 Clovis has also withdrawn its Marketing Authorization Application of rociletinib with European regulatory authorities.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
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