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Nov 29, 2020 // -- Ono Pharmaceuticals and Bristol-Myers Squibb K.K., the Japanese subsidiary, recently jointly announced the anti-PD-1 therapy Opdivo (Odivo, generic name: nivolumab, Navuliyu monotherapy) and anti-CTLA-4 therapy Yer Voy (ipilimumab, iplimumab) has been approved in Japan for first-line treatment of non-excisible advanced or relapsed non-small cell lung cancer (NSCLC) patients, including: (1) Opdivo-Yervoy programme;
these approvals are based on data from two Phase 3 clinical studies conducted by Ono Pharmaceuticals and Shishi Shiguibo.
The Opdivo-Yervoy and Opdivo-chemotherapy programs are based on the results of the CheckMate-227 study, and the Opdivo-Yervoy-chemotherapy program is based on the results of the CheckMate-9LA study.
Opdivo and Yervoy are immuno-checkpoint inhibitors with potential synergistic mechanisms that can work against two different immune checkpoints (PD-1 and CTLA-4) to help destroy tumor cells.
Yervoy helps activate and multiply T-cells, while Opdivo helps existing T-cells detect tumors.
, some T cells stimulated by Yervoy also become memory T cells, which can lead to long-term immune responses.
The Opdivo-Yervoy (OY combination) is the first dual immunotherapy to receive regulatory approval.
to date, the OY portfolio has been approved for six therapeutic adaptations to five types of cancer, including: melanoma, renal cell carcinoma, colorectal cancer, hepatocellular carcinoma, and non-small cell lung cancer.
Ono Pharmaceuticals, the original developer of Opdivo, between the company and Shishi Shiguibo in 2011, authorized the development and commercialization rights of PaxTrol Opdivo in addition to Japan, South Korea and Taiwan.
July 2014, the two sides further expanded their strategic partnership to develop and commercialize a wide range of immunotherapy treatments, including monotherapy and combination therapies, for cancer patients in Japan, Korea, and Taiwan, China.
, Opdivo has been approved in Japan, South Korea, China, the United States and the European Union.
the original source: Combin Therapy concerning Opdivo and Yervoy approved in Japan for First-Line Treatment of Unresect Advanced or Re-Noncurrent-Small Cell Lung Cancer