A phase III trial will be needed to determine approvability of the Clovis Oncology Inc. agent rociletinib for the treatment of non-small cell lung cancer, the FDA Oncologic Drugs Advisory Committee recommended.
At a meeting April 12, ODAC in effect voted against granting an accelerated approval of rociletinib for the treatment of patients with mutant epidermal growth factor receptor non-small cell lung cancer who have been previously treated with an EGFR-targeted therapy and have the EGFR T790M mutation as detected by an FDA approved test.
The question posed to the committee was whether the results of a randomized trial would be needed for FDA to make a regulatory decision on this application. All but one of the committee members voted in the affirmative, amounting to a 12 to 1 vote against. The Clovis TIGER-3 phase III, randomized, controlled trial is expected to be completed in late 2018.