Re­al-time re­views for cell and gene ther­a­pies? Pfiz­er to FDA: Yes, please

The FDA’s On­col­o­gy Cen­ter of Ex­cel­lence has a pro­gram, known as Re­al-Time On­col­o­gy Re­view (RTOR), that speeds up can­cer drug ap­provals, some­times by months, but has al­ways been re­strict­ed to can­cer drugs — first with sup­ple­ments and then mov­ing on to full ap­provals.

How RTOR works: Ear­li­er sub­mis­sions of topline ef­fi­ca­cy and safe­ty re­sults from spon­sors, pri­or to the sub­mis­sion of the com­plete ap­pli­ca­tion, help to sup­port an ear­li­er start to the FDA’s eval­u­a­tion of the com­plete ap­pli­ca­tion.

Endpoints News

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.