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Nivolumab Receives FDA Breakthrough Therapy Designation for Advanced/Metastatic Urothelial Carcinoma

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Bristol-Myers Squibb Company announced June 27 that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to nivolumab (Opdivo) for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen. As part of the Breakthrough Therapy Designation submission, the company shared for the FDA’s review results from the phase II CA209-275 study and other supportive data investigating nivolumab 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[nivolumab],” said Jean Viallet, MD, Global Clinical Research Lead, Oncology, Bristol-Myers Squibb. “As part of our commitment to bring [nivolumab]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 [CA209-275] 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 nivolumab 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 nonsquamous non–small cell lung cancer; and previously treated advanced or metastatic renal cell carcinoma. 

The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.


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