On July 4, 2014 Ono Pharmaceutical reported that it had received manufacturing and marketing approval for the human anti-human PD-1 monoclonal antibody "OPDIVO Intravenous Infusion 20 mg/100 mg"("OPDIVO") for the treatment of unresectable melanoma (Press release Ono, JUL 4, 2014, View Source [SID:1234500642]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Melanoma is considered to be a form of tumor characterized by the malignant transformation of pigment-producing cells located in the skin. In Japan, there has been an unmet need for an effective treatment for patients with surgically unresectable melanoma, who have an extremely poor prognosis that no treatment exists to significantly improve.

OPDIVO is a human anti-human PD-1 monoclonal antibody. PD-1 (programmed death-1), a receptor expressed on the surface of lymphocytes, plays a role in a regulatory pathway that suppresses activated lymphocytes in the body (negative signal). Available evidence suggests that cancer cells exploit this pathway to escape from immune responses. OPDIVO is thought to provide benefit by blocking PD-1-mediated negative regulation of lymphocytes (i.e., the interaction of PD-1 with its ligands PD-L1 and PD-L2), thereby enhancing the ability of the immune system to recognize cancer cells as foreign and eliminate them. OPDIVO is the world’s first approved drug targeting PD-1.

"We are delighted to obtain a manufacturing and marketing approval as a drug targeting PD-1, which receives a lot of attention in tumor immunity, for the first time in the world." said Gyo Sagara, the President and Representative Director of ONO. "ONO would like to obtain approvals for additional indications on ongoing development for other cancers to bring many patients OPDIVO as soon as possible."

Accumulating further clinical data is important in ensuring that OPDIVO will be used more safely and effectively. ONO is committed to taking actions necessary for the proper use of OPDIVO by implementing a post-marketing use-results survey (all-case surveillance) and collecting clinical data on the safety and efficacy of OPDIVO pursuant to the conditions for its approval.

Because of the very limited number of patients treated with OPDIVO in Japanese clinical trials, ONO is required to perform a post-marketing use-results survey covering all cases until data on a certain minimum number of patients have been accumulated. Through these activities, ONO should identify the characteristics of patients to be treated with OPDIVO and collect safety and efficacy data as soon as possible, thereby taking actions necessary to ensure the proper use of OPDIVO