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September 27, 2020 // -- Ono Pharmaceuticals and Bristol-Myers Squibb K.K., the Japanese subsidiary of Bristol-Myers Squibb K.K., have jointly announced that Japan's Ministry of Health, Labour and Labour (MHLW) has approved the anti-PD-1 therapy Opdivo (Eu Divo, generic name: nivolumab, navudan anti-CTLA-4 therapy Yervoy (ipilimumab, iplimumma), used to treat patients with advanced condition after chemotherapy, high microsatellita instability (MSI-H), non-excisive late stage or relapsed colorectal cancer.
In addition, Ono Pharmaceuticals announced that the four-week one-time administration of Opdivo monotherapy has also been approved: in the approved single-drug treatment adaptation, the current "intravenous infusion every 2 weeks 240 mg, each lasts 30 minutes" dose and the dosing schedule to add "intravenous infusion every 4 weeks 480 mg, each 30 minutes."
approval of the treatment of MSI-H colorectal cancer adaptation in the Opdivo-Yervoy immunological combination, based mainly on the results of the Opdivo-Yervoy combination queue in the multi-center, open-label Phase 2 clinical study CheckMate-142.
The study was conducted by Shishi Shiguibao in patients with advanced or relapsed CRC during or after receiving chemotherapy (including fluorine anticancer drugs) or who developed the disease, or who were insir to MSI-H or mismatch repair defects (dMMR).
results showed that the objective mitigation rate (ORR) of the Opdivo-Yervoy immunological combination was 55% in the study, which proved its effectiveness at the main endpoint.
study, the safety of the Opdivo-Yervoy immunological combination was consistent with the results of previous clinical studies, with no new safety signals.
Although Opdivo has been approved as a monotherapy treatment for MSI-H, non-excisive late stage or relapsed colorectal cancer, this latest approval allows Opdivo-Yervoy immunology combinations to treat the same adaptive disorders.
Opdivo-Yervoy is a unique combination of immuno checkpoint inhibitors with potential synergistic mechanisms for 2 different immune checkpoints (PD-1 and CTLA-4) and works in complementary ways 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 be regulatoryly approved.
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, 2011 built a partnership with Shimishi Shiguibo to authorize the development and commercialization of Thermay's Opdivo in addition to Japan, South Korea and Taiwan.
July 2014, the two sides further expanded their strategic cooperation in the development and commercialization of a wide range of immunotherapies, including monotherapy and combination therapies, for cancer patients in Japan, Korea and Taiwan, China.
so far, Opdivo has been approved in Japan, South Korea, China, the United States and the European Union.
origin of the original article: Opdivo and Yervoy Combin Therapy approved in Japan to Expand Use for the Treatment of The Treatment of The Statellite Des High (MSI-High) Colorectal Cancer, and Opdivo for Additional Dosage and Administration in Monotherapy Dos Regimeningn.