FDA sched­ules ad­vi­so­ry com­mit­tee hear­ing for Lyn­parza prostate can­cer ap­pli­ca­tion

What once ap­peared to be a slam dunk for Mer­ck and As­traZeneca’s PARP in­hibitor Lyn­parza may no longer be a sure thing.

The FDA will con­vene an ad­vi­so­ry com­mit­tee to dis­cuss an ap­pli­ca­tion to fur­ther ex­pand the drug’s la­bel in­to a broad­er set of prostate can­cer pa­tients, the com­pa­nies an­nounced Thurs­day morn­ing. The hear­ing, run by the On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee, or ODAC, will take place on April 28.

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