The Food and Drug Administration (FDA) has warned of an increased risk of death with duvelisib. The use of the drug is associated with a risk of severe adverse events.
Duvelisib for the treatment of chronic lymphocytic leukemia and small white blood cell lymphoma may increase the risk of death, the FDA warns. The corresponding statement was published on the regulator’s website.
The hazard ratio for death with duvelisib was 1.09 when compared with patients who received the monoclonal antibody ofatumumab. In the cohort of patients who had previously received two lines of systemic therapy, the hazard ratio was 1.06.
In addition, the incidence of grade 3 and 4 serious adverse events was also higher with duvelisib. Most often, patients experienced infections, diarrhea, inflammatory reactions of the intestines and lungs, skin reactions and increased liver transaminases.
The FDA made its conclusions based on the results of the DUO study, which assessed the five-year survival of 319 patients with chronic lymphocytic leukemia and small lymphocyte lymphoma. All participants had previously received other systemic therapy regimens that were ineffective. The mean follow-up time was 63 months.
The FDA recommends that patients discuss the risks and benefits of using the drug and the possibility of other treatments.
Duvelisib was approved by the FDA in 2018 for the treatment of patients with chronic lymphocytic leukemia and small lymphocyte lymphoma who have received at least 2 prior lines of systemic therapy. In Russia, the medicine was registered in 2021 for the treatment of relapsed and refractory follicular lymphoma.