FDA's on­col­o­gy ad­comm to re­view PI3K in­hibitors in blood can­cers in April

An at­trac­tive can­cer tar­get is go­ing to be in the hot seat at an FDA ad­vi­so­ry com­mit­tee on April 21.

The FDA’s on­co­log­ic drugs ad­vi­so­ry com­mit­tee, or ODAC, will specif­i­cal­ly dis­cuss a par­tic­u­lar class of can­cer drugs, known as phos­phatidyli­nos­i­tol-3-ki­nase, or PI3K, in­hibitors, that are cur­rent­ly un­der de­vel­op­ment in pa­tients with hema­to­log­ic ma­lig­nan­cies, or blood can­cers.

The out­side ad­vi­sors will dis­cuss whether ran­dom­ized da­ta should be re­quired to sup­port a demon­stra­tion of sub­stan­tial ev­i­dence of ef­fec­tive­ness and that the drug is safe for its in­tend­ed use.

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.