BMS nabs a sixth ‘breakthrough’ tag for Opdivo in bladder cancer


Bristol-Myers Squibb claims to have sewed up more than 80% of the U.S. and other major markets’ share of PD-1 spending with its Opdivo. Now, it’s moving ahead with its latest Breakthrough Therapy Designation, the sixth that the FDA has given for the immuno-oncology agent.

This time, the FDA has given the designation specifically for the indication of unresectable locally advanced or metastatic urothelial carcinoma that has progressed on or after a platinum-containing regimen. Last quarter, the pharma reported $704 million in Opdivo sales.

BMS said it expects to submit the PD-1 immune checkpoint inhibitor to the FDA “in the coming months” in this indication based on data from Phase II study CA209-275.

“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,” Dr. Jean Viallet, global clinical research lead in oncology at Bristol-Myers Squibb, said in a statement. “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.”

Opdivo already has the FDA’s Breakthrough Therapy Designation in 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 PD-1 immune checkpoint inhibitor was first approved by the FDA in December 2014. It works by binding to the checkpoint receptor PD-1 expressed on activated T cells and blocking the binding of PD-L1 and PD-L2, preventing the PD-1 pathway’s suppressive signaling on the immune system.

Roche ($RHHBY), via its Genentech subsidiary, recently got its first checkpoint inhibitor approval for Tecentriq (atezolizumab), which is also used to treat urothelial carcinoma.

- here is the release

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