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The FDA has approved durvalumab (Imfinzi, AstraZeneca) in combination with Bacillus Calmette-Guerin (BCG) for adults with BCG-naive, high-risk non-muscle-invasive bladder cancer (NIMBC).
Approval was based on findings from the randomized, open-label POTOMAC study of 1018 patients with high-risk NIMBC who had undergone transurethral bladder tumor resection, according to the FDA approval notice.
Patients who were randomized to durvalumab every 4 weeks for 13 cycles plus BCG induction and maintenance experienced significantly improved disease-free survival (DFS) vs those randomized to BCG induction and maintenance alone (hazard ratio, 0.68). Median DFS was not reached in either arm.
Prescribing information, which will be posted on Drugs@FDA, includes warnings and precautions for immune-mediated adverse reactions, infusion-relate reactions, complications of allogeneic hematopoietic stem cell transplantation, and embryo-fetal toxicities.
The recommended durvalumab dose for patients weighing at least 30 kg is 1500 mg every 4 weeks plus BCG induction and maintenance. Treatment should be continued for up to 13 cycles or until recurrence of high-risk disease, disease progression, or unacceptable toxicity occurs.
Sharon Worcester, MA, is an award-winning medical journalist based in Birmingham, Alabama, writing for Medscape, MDedge and other affiliate sites. She currently covers oncology, but she has also written on a variety of other medical specialties and healthcare topics. She can be reached at sworcester@mdedge.com or on X: @SW_MedReporter.
