Bristol Myers Squibb announces Opdivo FDA approval for urothelial carcinoma

In a significant stride toward enhancing bladder cancer treatment, Bristol Myers Squibb (NYSE: BMY) announced the U.S. Food and Drug Administration (FDA) approval of Opdivo (nivolumab), in conjunction with cisplatin and gemcitabine, for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), the most prevalent form of bladder cancer. This approval is underscored by the compelling findings from the Phase 3 CheckMate –901 trial, marking a pivotal moment in the management of a historically challenging disease.

Bristol Myers Squibb’s announcement about Opdivo’s approval is rooted in the results of the CheckMate -901 trial, which demonstrated a significant enhancement in overall survival (OS) and progression-free survival (PFS) among patients treated with Opdivo in combination with cisplatin and gemcitabine, compared to cisplatin-gemcitabine alone. Specifically, the trial showed a 22% reduction in the risk of death and a 28% reduction in the risk of disease progression or death for patients receiving the Opdivo combination therapy. These results not only underscore the effectiveness of Opdivo in treating UC but also highlight the potential for this combination therapy to change the standard of care for patients with unresectable or metastatic UC.

Guru P. Sonpavde, MD, Medical Director of Genitourinary Oncology at the AdventHealth Cancer Institute, lauded the approval as a significant advancement in a traditionally difficult-to-treat setting, emphasizing the potential of Opdivo in combination with chemotherapy to alter the treatment landscape for metastatic or unresectable UC. This sentiment is echoed by Wendy Short Bartie, senior vice president at Bristol Myers Squibb, who noted the approval as a testament to the company’s ongoing commitment to immunotherapy research and its impact on cancer treatment.

Opdivo’s approval comes with a detailed safety profile, cautioning against severe immune-mediated adverse reactions and other potential risks. The drug’s history of approvals for different stages and conditions within UC further demonstrates its versatility and the breadth of its impact on bladder cancer treatment.

The FDA’s decision to grant Priority Review status and approve Opdivo under the Real-Time Oncology Review (RTOR) pilot program highlights the agency’s commitment to expediting access to effective cancer treatments. Additionally, the review under the FDA’s Project Orbis initiative indicates a global approach to evaluating new therapies, potentially extending the benefits of Opdivo to patients worldwide.

In conclusion, the FDA approval of Opdivo for the first-line treatment of unresectable or metastatic urothelial carcinoma represents a major breakthrough in bladder cancer care. By providing a new therapeutic option with proven efficacy, Bristol Myers Squibb continues to lead in the field of oncology, offering hope to patients facing this challenging disease.