PI3K in­hibitor hit with an in­creased death risk warn­ing from FDA af­ter fi­nal tri­al re­sults emerge

The FDA sent a fresh warn­ing on Thurs­day about Se­cu­ra Bio’s em­bat­tled PI3K in­hibitor Copik­tra (du­velis­ib), which may in­crease the risk of death and se­vere side ef­fects for pa­tients as a third-line treat­ment for adults with chron­ic lym­pho­cyt­ic leukemia (CLL) or small lym­pho­cyt­ic lym­phoma (SLL).

Copik­tra won ap­proval for both in­di­ca­tions in 2018, but the FDA now says that af­ter a me­di­an of 63 months fol­low-up in the Phase III that led to the ap­provals, the fi­nal over­all sur­vival re­sults showed a pos­si­ble in­creased risk of death for those tak­ing Copik­tra, with a haz­ard ra­tio of 1.09 (95% con­fi­dence in­ter­val [CI] 0.79, 1.51). In ad­di­tion, 80/160 of those en­rolled in the tri­al and on Copik­tra end­ed up dy­ing, com­pared with 70/159 of those on No­var­tis’ ofa­tu­mum­ab, FDA said.

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