The European Commission has greenlighted Bristol-Myers Squibb’s advanced melanoma combination treatment of Opdivo and Yervoy.
Clinical studies showed a 58 percent reduction in the risk of disease progression with the combo drug versus Yervoy monotherapy. Opdivo recently scored breakthrough therapy designation from the FDA for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck following chemotherapy, marking the drug’s fifth breakthrough therapy designation.
The combination is the first immuno-oncology combination approved in the EU, according to the company. BMS did not return a request for comment regarding pricing and launch plans by press time.