PRINCETON, N.J. - Bristol Myers Squibb (NYSE: NYSE:BMY) has announced the U.S. FDA approval of Opdivo, in combination with cisplatin and gemcitabine, for the first-line treatment of adults with unresectable or metastatic urothelial carcinoma (UC), a common form of bladder cancer.
This approval follows the results from the Phase 3 CheckMate -901 trial, which showed a statistically significant improvement in overall survival (OS) and progression-free survival (PFS) when compared to the use of cisplatin and gemcitabine alone.
The study, with a median follow-up of approximately 33 months, indicated that the combination treatment reduced the risk of death by 22%, with a median OS of 21.7 months versus 18.9 months for the control group. Additionally, the risk of disease progression or death was reduced by 28%, with a median PFS of 7.9 months compared to 7.6 months for those who received cisplatin and gemcitabine alone.
Exploratory analyses also revealed an objective response rate (ORR) of 57.6% for the combination therapy, compared to 43.1% for the standard treatment. The complete response (CR) rate and partial response (PR) rate were also higher in the Opdivo combination group.
This FDA approval is particularly significant as it represents the first concurrent immunotherapy-chemotherapy combination approved for this patient population in the United States. Dr. Guru P. Sonpavde, from the AdventHealth Cancer Institute, highlighted the potential of this treatment to change the standard care for metastatic or unresectable UC and offer new hope to patients.
The safety profile of the combination treatment was consistent with known side effects of Opdivo and chemotherapy, with serious adverse reactions occurring in 48% of patients. The most common adverse reactions included nausea, fatigue, musculoskeletal pain, constipation, decreased appetite, rash, vomiting, and peripheral neuropathy.
Opdivo's approval was expedited through the FDA's Real-Time Oncology Review (RTOR) pilot program and Project Orbis initiative, reflecting the agency's commitment to providing timely access to effective cancer treatments.
Bladder cancer is the sixth most common cancer in the U.S., with an estimated 83,190 new cases expected to be diagnosed in 2024. The majority of UC cases are diagnosed at an early stage, but there is a high risk of progression and recurrence post-surgery, underscoring the importance of new treatment options like Opdivo in combination with chemotherapy.
This article is based on a press release statement from Bristol Myers Squibb.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.