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.