Tumor immunotherapy! Ono has submitted a supplementary application for opdivo in Japan, increasing the dosage plan every four weeks

November 28, 2019 / BIOON / -- Ono pharmaceutical recently announced that it has submitted a supplementary application in Japan to change the approved marketing approved part of the production of intravenous infusion of anti-PD-1 monoclonal antibody opdivo (Chinese trade name: odivo, common name: nivolumab, nevumab), to include the additional single drug treatment dose and schedule The purpose of this application is to increase "480 mg IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV IV This partial change request will provide additional treatment selection dose and Administration (dose interval) schedule, so it is possible to design a flexible treatment plan based on the patient's medical conditions and clinical process This will lead to improved convenience for patients and caregivers, as the number of visits for patients and the burden on patients and caregivers may be reduced Opdivo is a programmed death-1 (PD-1) checkpoint inhibitor, which aims to block the interaction between PD-1 and its ligands, and make unique use of the human autoimmune system to help restore the anti-tumor immune response Opdivo was first approved in Japan in July 2014 It is the first PD-1 immunotherapy approved in the world The treatment indication is melanoma By using the human autoimmune system to fight against cancer, opdivo has become an important treatment option for a variety of cancers In Japan, Ono launched opdivo in September 2014 to treat unresectable melanoma Since then, opdivo has been approved for a variety of cancer indications in Japan, including: (1) non resectable, advanced or recurrent non-small cell lung cancer; (2) non resectable or metastatic renal cell cancer; (3) recurrent or refractory classic Hodgkin's lymphoma; (4) recurrent or metastatic head and neck cancer; (5) non resectable advanced or recurrent gastric cancer after chemotherapy Cancer; (6) unresectable advanced or recurrent malignant pleural mesothelioma after chemotherapy; (7) adjuvant treatment of melanoma In addition, Ono has also submitted a supplementary application for the treatment of microsatellite instability high (MSI-H) colorectal cancer and esophageal cancer by opdivo, and is carrying out clinical development projects including esophageal cancer, esophageal gastric junction cancer, small cell lung cancer, liver cell cancer, glioblastoma, urothelial cancer, ovarian cancer, bladder cancer, colorectal cancer, pancreatic cancer, biliary cancer and other cancers Eye Ono pharmaceutical is the original developer of opdivo In 2011, the company entered into a cooperation with Bristol Myers Squibb to authorize the development and commercialization rights of Bristol Myers Squibb except Japan, South Korea and Taiwan In July 2014, the two sides further expanded strategic cooperation to develop and commercialize multiple immunotherapies (including single drug and combination therapy) for cancer patients in Japan, South Korea and Taiwan Up to now, opdivo has been approved in more than 65 countries, including Japan, South Korea, China, the United States and the European Union Source of original text: ono submissions supplementary application for additional operativo intrinsic infection monthly dose and schedule in Japan