The firm has a development agreement for the drug with Bristol-Myers Squibb, who acquired Medarex in 2009, and announced Friday it has received manufacturing and marketing approval in Japan for the treatment of unresectable melanoma.
The drug is a human monoclonal antibody, which works by blocking programmed death-1 (PD-1) - proteins that can attract programmed cell death 1 ligand 1 (PD-L1) made by cancer cells which stop T cells from attacking a tumour – and therefore overcoming the body’s immune resistance.
PD-1 inhibitors are currently being developed by a number of big biopharmas, including Novartis, Roche, Merck & Co., AstraZeneca, as well as Bristol-Myers Squibb, who holds the marketing rights to Opidvo outside of Japan, Korea and Taiwan.
“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 Ono’s President Gyo Sagara.
“Ono would like to obtain approvals for additional indications on ongoing development for other cancers to bring many patients OPDIVO as soon as possible.”