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FDA Grants Priority Review to Bristol Myers Squibb's Opdivo Combination for Urothelial Carcinoma


The FDA assigned a PDUFA date of April 5, 2024 for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma.

The FDA has granted Priority Review status to a supplemental Biologics License Application (sBLA) from Bristol Myers Squibb for Opdivo (nivolumab) plus cisplatin-based chemotherapy for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma (UC). The sBLA was given a Prescription Drug User Fee Act (PDUFA) goal date of April 5, 2024.1

Image credit: SciePro | stock.adobe.com

Image credit: SciePro | stock.adobe.com

“The FDA’s acceptance of our application for Opdivo in combination with cisplatin-based chemotherapy represents important progress toward addressing the unmet need for options that may offer durable responses and improved survival for patients with metastatic urothelial carcinoma. There remains a clear need for efficacious first-line treatment options that may potentially help improve outcomes for patients with this hard-to-treat disease,” Dana Walker, MD, MSCE, vice president, global program lead, gastrointestinal and genitourinary cancers, Bristol Myers Squibb, said in a press release.1 “We look forward to working with the FDA throughout the review of this application and hope to bring the first immunotherapy-chemotherapy combination to these patients in the U.S. We want to offer a special thanks to the patients and investigators involved in the CheckMate -901 clinical trial.”

The FDA awarded priority status to the sBLA based on findings from the Phase 3 CheckMate -901 study. The open-label trial randomly assigned 608 patients with metastatic disease and cisplatin chemotherapy-eligibility to receive either Opdivo (360 mg; intravenous [IV]) and cisplatin (gemcitabine–cisplatin; Opdivo combination) every three weeks for a maximum of six cycles, followed by 480 mg Opdivo every four weeks for up to two years or cisplatin every three weeks for a maximum of six cycles.2

The results showed a statistically significant and clinically meaningful survival benefit for the primary efficacy endpoints of overall survival (OS) and progression-free survival (PFS) as assessed by Blinded Independent Central Review (BICR) compared with standard-of-care gemcitabine plus cisplatin in the treatment of unresectable or metastatic UC.

The OS rate was 70.2% in the Opdivo treatment group compared to 46.9% in the gemcitabine–cisplatin alone cohort among patients eligible to receive cisplatin treatment. At median follow-up of 33.6 months, median OS was 21.7 months in the Opdivo-combination therapy cohort compared with 18.9 months in the gemcitabine–cisplatin group.2

Median PFS was 7.9 months in the Opdivo cohort compared with 7.6 months for the cisplatin cohort. Rates of PFS at 12 months were 34.2% with the Opdivo combination vs. 21.8% with gemcitabine–cisplatin. At 24 months, median PFS was 23.5% with the Opdivo combination vs. 9.6% with gemcitabine–cisplatin.2

In terms of safety, the profile for the Opdivo cohort was tolerable and consistent with the previously established safety profiles for the individual components of the regimen, with no new concerns identified.

UC is responsible for 90% of total bladder cancer cases. Approximately half of patients with UC experience disease recurrence or progression within a few years of primary surgery to remove the tumor, with up to 25% of these patients developing metastatic disease. First-line treatment for metastatic disease is chemotherapy, which is not associated with a durable response.1

Bristol Myers Squibb noted that Opdivo and combinations using the drug have produced significant improvements in OS across Phase 3 clinical trials for multiple types of tumors, including metastatic UC, advanced renal cell carcinoma, non-small cell lung cancer, malignant pleural mesothelioma, metastatic melanoma and esophageal squamous cell carcinoma.1


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... Bristol Myers Squibb. News release. December 5, 2023. Accessed December 5, 2023. https://news.bms.com/news/corporate-financial/2023/U.S.-Food-and-Drug-Administration-Accepts-for-Priority-Review-Bristol-Myers-Squibbs-Application-for-Opdivo-nivolumab-in-Combination-with-Cisplatin-Based-Chemotherapy-for-the-First-Line-Treatment-of-Adult-Patients-with-Unresectable-or-Metastatic/default.aspx

2. Jeijden MS, Sonpavde G, Powles T, et al. Nivolumab plus Gemcitabine–Cisplatin in Advanced Urothelial Carcinoma. The NEJM. October 22, 2023. Accessed December 5, 2023. DOI:10.1056/NEJMoa2309863.

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