On Tuesday, April 12, 2016, the Oncologic Drugs Advisory Committee (ODAC) did not support approval of rociletinib tablets by Clovis Oncology, Inc. (Clovis). Rociletinib was proposed for accelerated approval in 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.
A majority of the Committee members voted that the confirmatory clinical trial (named TIGER-3) should be submitted before FDA makes a regulatory decision on the NDA. The Committee’s vote was 12-Yes and 1-No, with no abstentions. The Prescription Drug User Fee Act (PDUFA) goal date for the NDA is June 28, 2016.