Categorized | Of Interest

Unresectable melanoma treatment approved in Japan

Source: July 2014

Ono Pharmaceuticals announced that its human anti-human PD-1 monoclonal antibody intravenous infusion 20 mg/100 mg, Opdivo, has been approved in Japan for manufacturing and marketing purposes for the treatment of unresectable melanoma.

The treatment is believed to provide benefit by blocking PD-1 mediated negative regulation of lymphocytes, which enhances the immune system’s ability to recognize cancer cells as foreign and eliminate them, according to a company press release.

“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,” Gyo Sagara, president and representative director of Ono, said in the press release. “Ono would like to obtain approvals for additional indications on ongoing development for other cancers to bring as many patients Opdivo as soon as possible.”

The company plans to collect more clinical data and post-marketing use-results survey data on Opdivo to ensure its safe and effective use, according to the release.

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