Background Analysis: US FDA Advisory Committee to Review Rociletinib by Clovis for EGFR T790M Non-Small Cell Lung Cancer – APR 12, 2016
The US FDA has scheduled a half-day meeting of the Oncologic Drugs Advisory Committee (ODAC) for Tuesday, April 12, 2016, to 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.
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