Se­cu­ra Bio to keep of­fer­ing blood can­cer drug de­spite neg­a­tive ODAC vote, OS ques­tions

Se­cu­ra Bio says it has no plans to change the mar­ket­ing sta­tus of its PI3K in­hibitor Copik­tra (du­velis­ib), which won full ap­proval in Sep­tem­ber 2018 as a third-line treat­ment for re­lapsed or re­frac­to­ry chron­ic lym­pho­cyt­ic leukemia or small lym­pho­cyt­ic lym­phoma. Up­dat­ed piv­otal tri­al re­sults raised fresh safe­ty ques­tions about that ap­proval, and the FDA’s out­side on­col­o­gy ex­perts last Sep­tem­ber vot­ed 8-4 against the drug’s ben­e­fit-risk pro­file.

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