FDA warns about potential elevated risk for death with blood cancer therapy
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The FDA issued a warning about a potentially increased risk for death or serious adverse effects with duvelisib, an approved blood cancer therapy.
Duvelisib (Copiktra, Secura Bio) — a PI3 kinase inhibitor — is approved in the United States to treat patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (SLL) who received at least two prior therapies.
Information about survival or risk for death was limited at the time of the agent’s approval in 2018, and the FDA required longer follow-up from the randomized phase 3 DUO trial.
The open-label trial included 319 patients with previously treated CLL or SLL.
Final 5-year survival results showed a possible increased risk for death with duvelisib compared with ofatumumab (Kesimpta, Novartis), a monoclonal antibody. Results also showed higher rates of serious adverse effects — including infections, diarrhea, inflammation of the intestine and lungs, and elevated liver enzyme levels in the blood — and deaths resulting from these events among durelisib-treated patients.
These findings appeared similar to those for other medicines from the PI3 kinase inhibitor class, according to the FDA.
“We are notifying the public of these risks and are continuing to evaluate the safety of Copiktra,” an FDA drug safety communication read. “We plan to hold a future public meeting to discuss the findings from the clinical trial and whether Copiktra should continue to be prescribed for patients. We will update the public when we have more information.”
The FDA urged patients to talk with their health care providers about the benefits and risks of receiving duvelisib.
“Health care professionals should consider the risks and benefits of continuing Copiktra in the context of other available treatments,” the FDA stated in its drug safety communication. “Advise patients receiving Copiktra of the possible increased risk of death and higher risk [for] serious adverse events.”
Health care providers are urged to report adverse events involving duvelisib to the FDA MedWatch program.
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