Posted by Michael Wonder on 27 Jun 2016
Bristol-Myers Squibb’s Opdivo (nivolumab) receives breakthrough therapy designation from U.S. FDA for advanced form of bladder cancer
27 June 2016 - This milestone marks the sixth breakthrough therapy designation for Opdivo.
Bristol-Myers Squibb announced today that the U.S. 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. 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.
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.
