Ono Pharma files for approval of nivolumab for melanoma in Japan

Japanese drugmaker Ono Pharmaceutical (TYO: 4528) has filed an application to obtain a manufacturing and marketing approval in Japan for its nivolumab (ONO-4538/BMS-936558) for treatment of malignant melanoma.

Nivolumab is a fully-human lgG4 PD-1 immune checkpoint inhibitor. PD-1 is one of the receptors expressed on activated lymphocytes, and is involved in a negative regulatory system to suppress the activated lymphocytes (a negative signal). It has been reported that tumor cells utilize this system to escape from the host immune responses.

Nivolumab is expected to have anti-tumor activity by blocking the interaction of PD-1 with its ligands (PD-L1 and PD-L2), preventing the negative regulatory signal mediated by the receptor (PD-1)-ligand interaction and thereby promoting the host immune response in which tumor cells and viruses are recognized as foreign and eliminated. Nivolumab was designated as an orphan drug indicated for malignant melanoma by Japan’s Ministry of Health, Labor and Welfare on June 17.