Secura’s Copiktra: Trial Design, Shifting Standard Of Care Could Spell The End For Third-Line CLL/SLL

23 Sep 2022

In concluding benefits do not outweigh risks in the drug’s current indication, US FDA advisory committee members cite concerns about survival data from the Phase III DUO trial, as well as the drug’s toxicities, safety issues with the PI3K inhibitor class, and the changing treatment landscape for chronic lymphocytic leukemia and small lymphocytic lymphoma.

Changing landscape — The changing therapeutic landscape in CLL/SLL has influenced the FDA's reconsideration of Copiktra's benefit-risk profile. • Source: Shutterstock

The benefit-risk profile for Secura Bio, Inc.’s Copiktra (duvelisib) is not favorable in its current indication for third-line treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), a US Food and Drug Administration advisory committee said on 23 September.

In voting 8-4 that the drug’s benefits do not outweigh its risks, Oncologic Drugs Advisory Committee members in the majority...