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FDA grants Opdivo breakthrough therapy designation for advanced bladder cancer
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The FDA granted breakthrough therapy designation to nivolumab for patients with unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.
The decision was based, in part, on results from the phase 2 CA209-275 study, which is evaluating the use of nivolumab (Opdivo, Bristol-Myers Squibb) in patients with metastatic or unresectable bladder cancer.
“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,” Jean Viallet, MD, global clinical research lead of oncology at Bristol-Myers Squibb, said in a press release. “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.”
Nivolumab has received FDA breakthrough therapy designation for recurrent or metastatic squamous cell carcinoma of the head and neck, Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab vedotin (Adcetris, Seattle Genetics), previously treated advanced melanoma, previously treated nonsquamous non–small cell lung cancer, and previously treated advanced or metastatic renal cell carcinoma.