Clovis Oncology Completes U.S., E.U. Regulatory Submissions For Rociletinib

(RTTNews) - Clovis Oncology, Inc. (CLVS) said it has submitted its New Drug Application regulatory filing to the U.S. Food and Drug Administration for rociletinib for the treatment of patients with mutant epidermal growth factor receptor or EGFR non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.

Rociletinib is the company's novel, oral targeted covalent (irreversible) mutant-selective inhibitor of EGFR in development for the treatment of non-small cell lung cancer or NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M.

Rociletinib was granted Breakthrough Therapy designation by the U.S. FDA in May 2014.

Clovis has also submitted its Marketing Authorization Application to the European Medicines Agency through the centralized procedure for rociletinib for the treatment of adult patients with mutant EGFR NSCLC who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.

There is a validation period before both applications are formally accepted, after which the review begins.