The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted 8-4 against the Copiktra risk-benefit profile, as reported in this September 23, 2022, Endpoint News article, “FDA adcomm takes down Secura Bio’s leukemia drug after final trial results show potential OS detriment”.
From that recent news report about the safety of Copiktra (duvelisib):
ODAC chair Jorge Garcia said ultimately these data do not support that this agent prolongs life. Other panelists who voted against it said, “We are playing with fire,” and that it didn’t meet the bar for safety, and that the data are hard to interpret and have concerns about this class of medicines.
And we were directed to some additional information about the Copiktra risk-benefit profile in his September 22, 2022, Fierce Pharma article, “FDA threatens to clamp down on another PI3K blood cancer drug—this time a full approval”:
In a briefing document prepared for an FDA oncology advisory committee meeting set to take place Sept. 23, the FDA laid bare its concerns over the toxicity of Secura Bio’s Copiktra and how the drug could detrimentally impact the life expectancy of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).
Recapping, at a September 2022 Advisory Committee Meeting, the FDA was asking its external experts to weigh in on whether the Copiktra risk-benefit profile is still favorable as a third-line CLL/SLL cancer treatment, and the majority of those experts voted “No”.
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