Ono Pharma gets South Korea approval of Opdivo

Japanese drugmaker Ono Pharmaceutical (TYO: 4528) has received approval from South Korea’s Ministry of Food and Drug Safety (MFDS) for its New Drug Application for the human anti-human PD-1 monoclonal antibody Opdivo (nivolumab) for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab (Yervoy) and, if BRAF V600E mutation positive, a BRAF inhibitor.

Ono, which is co-developing Opdivo under license from US pharma major Bristol-Myers Squibb (NYSE: BMY), will manufacture its finished product (vial product) and supply it to Ono Pharma Korea (OPKR).

In South Korea, there has been an unmet need for an effective treatment for patients with melanoma, who have limited treatment options available for patients who have been previously treated with approved agents.