ODAC: Duvelisib lacks favorable benefit-risk profile in CLL, small lymphocytic lymphoma
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An FDA advisory panel voted 8-4 that duvelisib did not have a favorable benefit-risk profile for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received at least two prior therapies.
The FDA Oncologic Drugs Advisory Committee made its decision after considering an update of the new drug application for the PI3 kinase inhibitor, which has been approved for this patient population.
In June, FDA issued a warning about the potential risk for death and serious adverse events with duvelisib (Copiktra, Secura Bio). Five-year OS data from the DUO trial, provided to FDA as part of a postmarketing requirement, showed a possible detriment to OS. FDA also noted that existing data showed substantial toxicity and poor tolerability, as well as concerns about the selected dose and the PI3 kinase inhibitor class of drugs.
The sponsor asserted that the evidence does not support a detrimental impact on OS and that the benefit-risk profile of the agent remains positive.
“I do have concerns about this class of medications,” committee member Christopher H. Lieu, MD, gastrointestinal medical oncologist and associate director for clinical research at University of Colorado Cancer Center, said after casting his vote. “If we’re not clearly improving overall survival in our patients, but we’re increasing toxicity and treatment-associated death, I’m not sure that we’re truly helping patients.”
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