FDA ad­comm takes down Se­cu­ra Bio's leukemia drug af­ter fi­nal tri­al re­sults show po­ten­tial OS detri­ment

The FDA’s On­co­log­ic Drugs Ad­vi­so­ry Com­mit­tee on Fri­day vot­ed 8-4 against the ben­e­fit-risk pro­file of Se­cu­ra Bio’s PI3K in­hibitor Copik­tra (du­velis­ib), which won ap­proval in Sep­tem­ber 2018 as a third-line treat­ment for re­lapsed or re­frac­to­ry CLL or SLL, but up­dat­ed piv­otal tri­al re­sults raised safe­ty ques­tions.

In ad­di­tion to the se­ri­ous and fa­tal tox­i­c­i­ties of du­velis­ib, FDA speak­ers at the ODAC meet­ing point­ed to an evolved treat­ment land­scape for CLL and SLL, with tar­get­ed BTK or BCL2 in­hibitors (front-line or sec­ond-line), and da­ta point­ing to a “po­ten­tial detri­ment” in over­all sur­vival for du­velis­ib. But some ODAC mem­bers not­ed that the detri­ment was like­ly small and that there is some ef­fi­ca­cy even as the da­ta are dif­fi­cult to in­ter­pret.

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