Clovis Oncology files NDA at FDA for rociletinib to treat non-small cell lung cancer with the EGFR T790M mutation

Clovis Oncology, Inc.announced that it has commenced the submission of a New Drug Application (NDA) regulatory filing to the FDA for rociletinib for the treatment of patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC) 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 NSCLC in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M. Rociletinib was granted Breakthrough Therapy designation by the FDA in May 2014. Clovis agreed with FDA that the submission would be a rolling NDA and has filed the first component for potential accelerated approval of rociletinib in the U.S. The rolling NDA allows completed portions of an NDA to be submitted and reviewed by the FDA on an ongoing basis. The Company intends to complete the NDA submission by late July 2015 In addition, the Company intends to complete the Marketing Authorization Application (MAA) for rociletinib to the European Medicines Agency at the end of July.

Comment: There are no approved treatment options for patients with non-small cell lung cancer who have developed the T790M resistance mutation. Rociletinib will compete with AstraZeneca's AZD 9291 and both drugs are comparable in terms of efficacy, with a response rate in the high 50%s and 60%s, with rociletinib hoping to distinguish itself with a better safety profile and solid evidence of a long-lasting impact on many patients.