Issue: Whether Copiktra Risk-Benefit Profile is Still Favorable as a Third-Line CLL/SLL Cancer Treatment; Final Vote: "No"
We concluded our July 5, 2022 article, "Using Copiktra for Leukemia or Lymphoma May Increase Risks of Serious Side Effects and Death", stating that we would be watching a future FDA Advisory Committee Meeting that will discuss the safety of Copiktra and, in turn, for any significant developments about the Copiktra risk-benefit profile as regards it being prescribed for chronic lymphocytic leukemia (CLL) and/or small lymphocytic lymphoma (SLL) cancer patients.
On September 23, 2022, the FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 8-4 against the Copiktra risk-benefit profile, as reported in this Endpoint News piece by Senior Editor Zachary Brennan, "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):
In addition to the serious and fatal toxicities of [Copiktra (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 [Copiktra (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.
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.
But those voting in favor of [Copiktra (duvelisib)] said it should remain an option....
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We were directed to some additional information about the Copiktra risk-benefit profile by Fierce Pharma reporter Angus Liu in his September 22, 2022 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).
As the FDA sees it, Copiktra speaks to a PI3K classwide safety problem, which was already discussed during an FDA expert panel meeting in April. Feeling the pressure from that FDA scrutiny, Gilead Sciences, Bayer, Incyte and TG Therapeutics have either pulled their PI3K indications off the market or scrapped their application plans. But Secura doesn’t want to go down without a fight.
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".
We will watch to see what action the FDA or Secura takes next, following this recent Copiktra risk-benefit profile decision.
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