Added approval for Opdivo in South Korea

Japanese drugmaker Ono Pharmaceuticals (TYO: 4528) says it South Korean subsidiary, Ono Pharma Korea (OPKR) has received supplemental approval of Opdivo (nivolumab) intravenous infusion from the Korean Ministry of Food and Drug Safety (MFDS), for expanded use for the treatment of patients with unresectable or metastatic melanoma.

Melanoma is a type of cancer that develops from the pigment-containing cells known as melanocytes having a capacity to produce melanin deeply related to skin color, with an estimated about 1,400 patients per year in Korea. Opdivo has been approved for the treatment of patients with BRAF V600E wild-type unresectable or metastatic melanoma as a single agent therapy. This approval allows Opdivo to be used in patients with BRAF mutation-positive unresectable or metastatic melanoma. In combination with Yervoy (ipilimumab), Opdivo has been approved for the treatment of patients with or without BRAF mutation unresectable or metastatic melanoma.

In addition, Ono has submitted supplemental application for additional indication of gastric cancer, and is conducting clinical development program including esophageal cancer, gastro-esophageal junction cancer, small cell lung cancer, hepatocellular carcinoma, glioblastoma, urothelial cancer, malignant pleural mesothelioma, ovarian cancer, biliary tract cancer, etc. Opdivo has regulatory approval in more than 60 countries including Japan, Taiwan, USA and European Union.