FDA Approval Insights: Perioperative Durvalumab Plus Chemo in MIBC: With Matthew Galsky, MD

In today’s episode, we spoke with Matthew Galsky, MD, about the FDA approval of neoadjuvant durvalumab (Imfinzi) plus gemcitabine and cisplatin followed by adjuvant durvalumab monotherapy after radical cystectomy for the treatment of adult patients with muscle-invasive bladder cancer (MIBC). Dr Galsky is a professor of medicine (hematology and medical oncology), a professor of urology, director of Genitourinary Medical Oncology, co-director of the Center of Excellence for Bladder Cancer, and director for Translational Research at The Tisch Cancer Institute in New York, New York.

In our exclusive interview, Dr Galsky discussed the significance of this approval, key efficacy and safety data from the pivotal phase 3 NIAGARA trial (NCT03732677), and the role of this regimen in the MIBC treatment paradigm, including for cisplatin-eligible patients with mild renal impairment.