U.S. FDA Approves Drug for the Adjuvant Treatment of Patients with High-Risk Urothelial Carcinoma
New Jersey-based Bristol Myers Squibb announced on September 20, 2021, that Opdivo®(nivolumab) 240 mg every two weeks or 480 mg every four weeks (injection for intravenous use) was approved by the U.S. Food and Drug Administration (FDA) for the adjuvant treatment of patients with urothelial carcinoma (UC) who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement or PD-L1 status.
The FDA approval is based on the Phase 3 CheckMate -274 trial, which compared Opdivo 240 mg (n=353) to placebo (n=356).
"This approval is a major milestone for patients who have undergone major surgery to remove the bladder or parts of the urinary tract and require additional treatment approaches that can help reduce the risk of their UC returning," commented Matthew D. Galsky, M.D., a CheckMate -274 primary investigator and Professor of Medicine, Director of Genitourinary Medical Oncology, Co-Director of the Center of Excellence for Bladder Cancer, and Associate Director for Translational Research at The Tisch Cancer Institute and the Icahn School of Medicine at Mount Sinai.
"Nivolumabprovides a new FDA-approved treatment shown to reduce the risk of disease recurrence or death based on the safety and efficacy findings from CheckMate -274, and has the potential to become a new standard of care option in this setting," added Dr. Galsky in a related press release.
This application was approved under the FDA's Real-Time Oncology Review pilot program, which aims to ensure that safe and effective treatments are available to patients as early as possible.
Urothelial carcinoma most frequently begins in the cells that line the inside of the bladder, which is the most common type of bladder cancer in adults in the United States. Each year, 81,000 new cases of bladder cancer are diagnosed, and a majority of those cases are UC. In addition to the bladder, UC can occur in other parts of the urinary tract, including the ureter and renal pelvis.
In 2011, through a collaboration agreement with Ono Pharmaceutical Co., Bristol Myers Squibb expanded its territorial rights to develop and commercialize Opdivo globally, except in Japan, South Korea, and Taiwan, where Ono had retained all rights to the compound at the time. On July 23, 2014, Ono and Bristol Myers Squibb further expanded the companies' strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agents and combination regimens – for patients with cancer in Japan, South Korea, and Taiwan.