Mer­ck, Roche and Bris­tol My­ers nab 4 of 6 pos­i­tive ODAC votes for ‘dan­gling’ ac­cel­er­at­ed ap­provals

What looked at the out­set like a prime op­por­tu­ni­ty for the FDA to cri­tique in­dus­try over failed con­fir­ma­to­ry tri­als for lag­ging ac­cel­er­at­ed ap­provals end­ed up be­ing most­ly a tri­umph for the large bio­phar­ma com­pa­nies.

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee vot­ed in fa­vor of keep­ing on the mar­ket four of the six “dan­gling” ac­cel­er­at­ed ap­provals pre­sent­ed to it over the last three days. Even de­spite the failed tri­als, com­pa­nies and their physi­cians raised con­cerns about un­met treat­ment needs and the long du­ra­tion of re­spons­es for the check­point in­hibitors be­fore each of the six votes.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER