FDA Issues New Warning for Copiktra About Increased Risks for Serious Side Effects and Mortality

September 2022, Vol 12, No 9

On June 30, 2022, the FDA issued a new boxed warning for duvelisib (Copiktra; Secura Bio) about the increased risk for serious side effects and death with this PI3K inhibitor, based on the result of the DUO clinical trial. Duvelisib is approved for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) in adults after at least 2 previous therapies. Prophylaxis for Pneumocystis jirovecii is recommended during treatment with duvelisib.

The DUO trial was a phase 3, randomized, open-label study that compared duvelisib therapy and the monoclonal antibody ofatumumab (Kesimpta; Novartis) in 319 patients with relapsed or refractory CLL or SLL who received at least 1 previous therapy.

At a median follow-up of 63 months, the results showed an increased mortality risk with duvelisib versus with ofatumumab (hazard ratio [HR], 1.09; 95% confidence interval [CI], 0.79-1.51). In patients who received ≥2 previous lines of therapy, the HR for mortality was 1.06 (95% CI, 0.71-1.58). The median overall survival was lower with duvelisib than with ofatumumab (52.3 months vs 63.3 months, respectively).

A safety analysis showed more serious adverse reactions (including grade ≥3), increased treatment modifications resulting from adverse reactions, and a higher incidence of death because of adverse reactions with duvelisib than with ofatumumab.

The FDA is continuing to evaluate the safety of duvelisib and is planning a meeting to discuss the clinical trial findings and whether the drug can continue to be prescribed for patients.

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