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FDA Postpones Decision on Lung Cancer Drug Rociletinib
The FDA has extended the Prescription Drug User Fee Act (PDUFA) date for the new drug application pertaining to rociletinib (Clovis Oncology) by the standard extension period of three months, with a new goal date of June 28, 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 treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
Clovis Oncology submitted a major amendment to the FDA in November 2015 in response to the agency’s request for additional clinical data for both the 500-mg and 625-mg twice-daily dosages of rociletinib. The FDA extended the PDUFA goal date to allow additional time for review of the new information.
Rociletinib is an oral, targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of NSCLC in patients with initial activating EGFR mutations as well as the dominant resistance mutation T790M. Data from the pivotal, single-arm TIGER-X and TIGER-2 clinical trials served as the basis for the U.S. regulatory submission for the treatment of patients with advanced mutant EGFR T790M-positive lung cancer.
Rociletinib was granted a breakthrough therapy designation in May 2014.
Source: Clovis Oncology; December 15, 2015.