Issue: November 10, 2015
October 09, 2015
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FDA grants priority review to rociletinib for advanced NSCLC
Issue: November 10, 2015
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The FDA granted priority review to a new drug application for rociletinib.
Rociletinib (Clovis Oncology) — a novel, oral, targeted covalent mutant-selective epidermal growth factor receptor inhibitor — is intended for patients with advanced EGFR-mutant, T790M-positive non–small cell lung cancer who already received EGFR-targeted therapy.
The FDA is expected to make a decision about the agent’s status by March 30, 2016.
The agency based its priority review designation on results of the single-arm TIGER-X and TIGER-2 clinical trials, which evaluated rociletinib in patients with advanced EGFR-mutant NSCLC whose tumors harbor a T790M mutation.
The FDA granted breakthrough therapy designation to rociletinib in May 2014.