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news.Bristol-Myers Squibb announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to Opdivo for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.
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As part of the Breakthrough Therapy Designation submission, the Company shared for the FDA’s review results from Phase 2 study CA209-275 and other supportive data investigating Opdivo in these previously treated bladder cancer patients.
"Urothelial cancer is a common type of bladder cancer where patients experience high rates of recurrence and remains an area where new treatment approaches are needed, further underscoring the importance of this designation for Opdivo," said Jean Viallet, M.D., Global Clinical Research Lead, Oncology, Bristol-Myers Squibb.
"As part of our commitment to bring Opdivo to these advanced bladder cancer patients as quickly as possible, we look forward to filing a marketing application with health authorities based on results from study -275 and other supporting data in the coming months, as well as submitting the data for presentation at an upcoming medical meeting."
The Breakthrough Therapy Designation is an FDA program intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases to help ensure patients have access to new therapies as soon as possible. According to the FDA, the criteria for a Breakthrough Therapy Designation requires preliminary clinical evidence that demonstrates the medicine may have substantial improvement on at least one clinically significant endpoint over available therapy.
Previous Breakthrough Therapy Designations granted for Opdivo by the FDA include previously treated recurrent or metastatic squamous cell carcinoma of the head and neck, Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab-vedotin, previously treated advanced melanoma, previously treated non-squamous non-small cell lung cancer, and previously treated advanced or metastatic renal cell carcinoma.
About Bladder Cancer
Bladder cancer, which typically begins in the cells that line the inside of the bladder, is the ninth most commonly diagnosed cancer in the world, with an estimated 430,000 new cases diagnosed per year and over 165,000 deaths per year. Urothelial carcinoma is the most common type of bladder cancer, accounting for approximately 90% of cases. The majority of bladder cancers are diagnosed at an early stage, but rates of recurrence and progression are high and approximately 78% of patients will experience a recurrence within five years. Survival rates vary depending on the stage and type of the cancer and when it is diagnosed. For Stage IV bladder cancer, the five-year survival rate is 15%.