Ono Pharma files for additional indication for Opdivo in Japan

23 April 2015

Japanese drugmaker Ono Pharmaceuticals (TYO: 4528) has submitted an additional indication application for the human anti-human programmed cell death-1 (PD-1) monoclonal antibody Opdivo (nivolumab) 20mg, 100mg Inj for the treatment of patients with unresectable, advanced or recurrent non-small cell lung cancer(NSCLC), except non-squamous cell carcinoma.

Ono received approval for the manufacturing and marketing of Opdivo to treat unresectable melanoma from Japan’s Ministry of Health Labor and Welfare (MHLW) last year (The Pharma Letter July 7, 2014).

The drug has been filed for approval in the lung cancer indication in the USA and Europe by Ono’s marketing partner, US pharma major Bristol-Myers Squibb (NYSE: BMY).

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