7 August 2017 - The Research Letter, “Quality of Life, Overall Survival and Costs of Cancer Drugs Approved Based on Surrogate Endpoints,” by Rupp and Zuckerman and the accompanying Editor’s Note “Improving the Accelerated Pathway to Cancer Drug Approvals” by Bauer and Redberg, both published in a recent issue of JAMA Internal Medicine, contain inaccuracies and misconceptions. 

Bauer and Redberg incorrectly state that Rupp and Zuckerman examined 18 oncology drugs that received accelerated approval (AA). A review of approval letters shows that among the 18 approvals and indications listed, 12 received regular approval (RA) with no post-marketing studies required to confirm benefit, 4 were granted AA and later RA after confirmation of benefit, 1 is under AA with confirmation pending, and 1 received AA with subsequent failure to confirm benefit.

Read JAMA Internal Medicine comment & response