Briefing Summary: US FDA Posts Advisory Committee Materials for Rociletinib by Clovis for EGFR T790M Non-Small Cell Lung Cancer – APR 12, 2016 (ODAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Tuesday, April 12, 2016, Oncologic Drugs Advisory Committee (ODAC) meeting. The Committee will discuss a new drug application (NDA 208542) for rociletinib tablets by Clovis Oncology, Inc. (Clovis). The proposed indication is 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.
See the SAC Tracker report