publication date: Apr. 25, 2016

Comparison with AstraZeneca Drug Hard to Ignore as ODAC Votes Down NSCLC Application from Clovis 


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.

Arguably the most interesting question on the table concerned another drug—AstraZeneca’s Tagrisso (osimertinib)—which has been granted an accelerated approval for the same indication. Since that agent’s approval is accelerated, it doesn’t raise the bar for competing drugs—such as rociletinib. Once Tagrisso’s approval switches from accelerated to regular, newcomers would need to show that they provide a superior safety or efficacy profile.

Much of ODAC’s discussion focused on cross-study comparisons, which, albeit inconclusive, suggest that the AstraZeneca drug has a better safety and efficacy profile. Such comparisons—which ODAC … Continue reading 42-16 Comparison with AstraZeneca Drug Hard to Ignore as ODAC Votes Down NSCLC Application from Clovis

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