FDA re­view­ers plot case for ran­dom­ized da­ta on blood can­cer PI3K in­hibitors ahead of ad­vi­so­ry meet­ing

The fate of fu­ture de­vel­op­ment of the PI3K in­hibitor class, in hema­to­log­ic ma­lig­nan­cies, will be de­cid­ed on Thurs­day as the FDA’s out­side ad­vi­sors meet to dis­cuss whether drug de­vel­op­ers should be re­quired to have ran­dom­ized da­ta to sup­port sub­stan­tial ev­i­dence of ef­fi­ca­cy and safe­ty.

Brief­ing doc­u­ments, post­ed Tues­day, show the FDA’s re­view­ers and sta­tis­ti­cians ap­pear in align­ment with com­ments made by the agency’s on­col­o­gy czar Richard Paz­dur last week.

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