Over 10 years lat­er, FDA of­fi­cial­ly pulls a BMS ac­cel­er­at­ed ap­proval, and a Te­va copy­cat falls with it

While for­mal­ly an­nounc­ing the with­draw­al of the pe­riph­er­al T-cell lym­phoma (PT­CL) in­di­ca­tion for Bris­tol My­ers Squibb’s Is­to­dax (ro­midepsin) for in­jec­tion (the com­pa­ny made a sim­i­lar an­nounce­ment last sum­mer) on Fri­day, the agency al­so said it’s pulling Te­va’s 505(b)(2) ap­pli­ca­tion, af­ter the can­cer drug failed its con­fir­ma­to­ry tri­al.

The fi­nal an­nounce­ment on the with­draw­al comes more than ten years af­ter the FDA ini­tial­ly grant­ed an ac­cel­er­at­ed ap­proval for Is­to­dax in PT­CL in 2011, re­veal­ing again just how long it can take the agency to fi­nal­ize such a with­draw­al, even when con­fir­ma­to­ry re­sults show fail­ure. The House En­er­gy & Com­merce com­mit­tee re­cent­ly in­tro­duced a mea­sure that would shore up that ac­cel­er­at­ed ap­proval with­draw­al process, but com­pa­nies will still be able to take re­quests for with­drawals be­fore ad­comms.

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