FDA Grants Priority Review to Bristol Myers Squibb’s Opdivo Plus Cisplatin-Based Chemotherapy for First-Line Treatment of Unresectable or Metastatic Urothelial Carcinoma

▎Edited by the WuXi AppTec content team

‍Bristol-Myers Squibb Company announced today that the U.S. FDA has accepted the supplemental Biologics License Application (sBLA) for the blockbuster PD-1 inhibitor Opdivo (nivolumab) in combination with cisplatin-based chemotherapy for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma. The FDA also granted this application Priority Review, with a decision expected by April 5, 2024. The press release noted,If approved, the Opdivo-based combination therapy will be the first immunotherapy/chemotherapy combination treatment for this patient population.

This application is supported by the Phase 3 clinical trial CheckMate-901. In this study, the combination of Opdivo and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful survival benefit compared to the standard treatment regimen in this patient population. Results presented at the European Society for Medical Oncology (ESMO) Congress showed that at a median follow-up of approximately 33 months,The combination of Opdivo and chemotherapy reduced the risk of death by 22% compared to chemotherapy alone. The median overall survival (OS) was 21.7 months in the Opdivo combination therapy group and 18.9 months in the control group (HR=0.78; 95% CI: 0.63, 0.96; p=0.0171).

In patients treated with Opdivo-based combination therapy, the risk of death or disease progression was reduced by 28%., the median progression-free survival (PFS) was 7.9 months vs. 7.6 months (HR=0.72; 95% CI: 0.59, 0.88; p=0.0012) compared with chemotherapy alone.

The combination of Opdivo with cisplatin-based chemotherapy demonstrated an acceptable safety profile, consistent with the known safety of the individual components. No new safety concerns were identified.

Opdivo is a PD-1 immune checkpoint inhibitor designed to help restore anti-tumor immune responses.By harnessing the body's own immune system to fight cancer, Opdivo has become an important treatment option for various types of cancer.

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References:

[1] U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Opdivo (nivolumab) in Combination with Cisplatin-Based Chemotherapy for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma. Retrieved December 5, 2023, from https://www.businesswire.com/news/home/20231204596253/en

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