Cancer Drug Copiktra Could Shorten Life Expectancy in Some Patients, FDA Reviewers Warn

FDA scientists says a new review of the drug's benefit-risk analysis is warranted.

The blood cancer drug Copiktra may reduce life expectancy for some cancer patients, according to federal drug regulators.

Scientists in the U.S. Food and Drug Administration (FDA) report that patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) appear to have slightly shorter lifespans if they take Copiktra, compared to those who take the competing drug Arzerra. Their findings were published in an FDA briefing document that will be presented at an FDA Oncologic Drugs Advisory Committee meeting taking place today.

Copiktra (duvelisib) is a Secura Bio blood cancer drug approved by the FDA in 2018. It belongs to a class of drugs called PI3K inhibitors, which the agency has become increasingly concerned are linked to shortened life expectancy. Other members of the class include Zydelig, Aliqopa and Ukoniq. The FDA raised concerns about the class during an advisory committee meeting in April.

TG Therapeutics removed Ukoniq from the market following the April meeting, and GlaxoSmithKline withdrew some uses of Zydelig after the meeting as well.

FDA reviewers say a five-year analysis of data found that third-line patients taking Copiktra lived a median of 43.9 months, compared to 46.8 months on Arzerra. In addition 9% of patients on Copiktra died from the drug’s side effects, with the main cause being deadly infections. That compares to just 3% of Arzerra patients.

“Substantial Toxicity” with Copiktra Side Effects

FDA reviewers found that side effects of Copiktra was associated with higher rates of serious adverse events and patients often required dose modifications due to adverse events.

“Duvelisib is associated with substantial toxicity that includes fatal or serious infection, diarrhea or colitis, rash, pneumonitis, hepatotoxicity, and neutropenia,” FDA reviewers wrote. “Based on the issues outlined above and discussed in detail in the remainder of the briefing document, there are significant concerns with the benefit-risk profile of duvelisib in patients with CLL or SLL. The concerns include a potential detriment in overall survival, substantial toxicity, tolerability concerns, and dosing concerns.”

As a result of the findings, FDA researchers warned that the 25 mg dose of Copiktra “appears to be too high.” However, they noted that clinical trials leading to Copiktra’s 2018 approval did not sufficiently explore the utility of lower doses, and adverse events appeared to be linked to doses as low as 8 mg.

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Many of the same patterns have been observed across the PI3K Inhibitor class, the reviewers noted. As a result, they are advising the committee that a re-evaluation of the overall benefit-risk profile of Copiktra may be needed.

The advisory committees are made up of researchers and experts in specific fields. They offer recommendations to the FDA, but cannot make regulations or take regulatory actions. The FDA is not bound to follow the advisory committees’ findings, but often weigh those recommendations heavily in its final decision-making process.


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