Opdivo Receives Breakthrough Therapy Designation for Advanced Bladder Cancer

The FDA has granted Bristol-Myers Squibb’s nivolumab (Opdivo) breakthrough therapy designation for the potential indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen.

The FDA based its decision on the results of a phase 2 study known as CA209-275, as well as other supporting data that investigated Opdivo as a treatment for previously treated bladder cancer patients.

“Urothelial cancer is a common type of bladder cancer where patients experience high rates of recurrence, and it 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.”

The FDA previously gave breakthrough therapy designations for Opdivo for the following indications: 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.