- Per FDA guidelines for Breakthrough Therapy-tagged drugs, Clovis Oncology (NASDAQ:CLVS) initiates its rolling New Drug Application (NDA) submission for rociletinib for the treatment of patients with mutant epidermal growth factor (EGFR) non-small cell lung cancer (NSCLC) who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation.
- Clovis expects to complete the submission by the end of this month as well as its Marketing Authorization Application (MAA) in Europe.
- Rociletinib (CO-1686) is a mutant-selective EGFR inhibitor.
- Previously: Clovis off premarket after report on CO-1686 (Nov. 19, 2014)