Fail­ing to con­firm clin­i­cal ben­e­fit, Gilead pulls 2 ac­cel­er­at­ed ap­proval in­di­ca­tions for can­cer drug

Gilead re­cent­ly de­cid­ed to pull two in­di­ca­tions for its can­cer drug Zy­delig — in re­lapsed fol­lic­u­lar B-cell non-Hodgkin lym­phoma (FL) and re­lapsed small lym­pho­cyt­ic leukemia (SLL) — af­ter fail­ing to com­plete the con­fir­ma­to­ry tri­als re­quired as part of the ac­cel­er­at­ed ap­provals from 2014.

“As the treat­ment land­scape for FL and SLL has evolved, en­roll­ment in­to the con­fir­ma­to­ry study has been an on­go­ing chal­lenge,” Gilead said in a state­ment, not­ing it for­mal­ly no­ti­fied the FDA of its de­ci­sion to vol­un­tar­i­ly with­draw these in­di­ca­tions.

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