英文药名：Yervoy Injection（ipilimumab[Genetical Recombination]）
Notification of manufacturing and marketing authorization to adapt "Yahboi (R) infusion intravenous solution 50 mg" to radical cureless malignant melanoma
Notification of manufacturing and marketing authorization to adapt to curative malignant melanoma of radical cure of human type anti-human CTLA-4 monoclonal antibody "YAVOY (R) drip infusion solution 50 mg"
The world's first approved immunity checkpoint inhibitor approved in Japan
Bristol-Myers Co., Ltd. (Shinjuku-ku, Tokyo, President: David Piras)
Regarding malignant melanoma that can not be cured remotely for human anti-human CTLA-4 monoclonal antibody "Yavoi (R) intravenous infusion solution 50 mg, hereinafter referred to as Yavoy" (generic name: ipilimumab (genetical recombination)), the Ministry of Health, Labor and Welfare We will inform you that we have obtained more manufacturing and sales approval.
Yahboi reported statistically significant overall survival (OS) as compared to the control group, regardless of BRAF mutation (Note 1) in overseas Phase III trials in patients with radical cure of malignant melanoma, It is the first drug in the world to show the extension of. It is also the first medicine approved in the world as an immunity checkpoint inhibitor called cancer immunotherapy, which has attracted a great deal of attention in cancer treatment in recent years. Since March 2011, it has been approved in the United States, including Europe, Australia and Canada, has been approved in more than 50 countries since it was approved for indications of unresectable or metastatic malignant melanoma. It is also used as a standard treatment for malignant melanoma that can not be cured curable irrespective of the treatment history of anticancer drugs in many countries.
Yahboi block inhibitory regulation in activated T cells by inhibiting the action of cytotoxic T lymphocyte antigen-4 (CTLA-4), a regulatory factor that suppresses the activation of T cells, It promotes antigen-specific T cell activation and proliferation, and suppresses tumor growth. It is also thought to exhibit an antitumor effect by increasing the tumor immune response by decreasing the function of regulatory T cells (Treg) and decreasing the number of Tregs in the tumor tissue.
David Piras, president and Representative Director of Bristol-Myers Co., said, "With the approval of Yahboi, the addition of new treatment options that can be expected to have long-term survival to patients in Japan who are struggling with malignant melanoma, As Bristol-Myers Squibb is a world leader in cancer immunotherapy, we will continue to develop and offer innovative medicines that can make a difference to patients with serious illness. " I said.
Yahboi's product overview
Product name: Yavoi (R) infusion IV 50 mg
Common name: ipilimumab (genetically modified)
Radical cure of malignant melanoma
Usually, as an ipilimumab (genetical recombination) to an adult, intravenous drip infusions are given 4 times once a day at 3mg/ kg (body weight) at intervals of 3 weeks.
Manufacturing marketing approval acquisition date: July 3, 2015
Manufacturer selling agency: Bristol-Myers Co., Ltd.
1. Formulate a pharmaceutical risk management plan and implement it appropriately.
2. Since the number of clinical trials in Japan is extremely limited, by conducting a usage result survey for all cases until data of a certain number of cases are accumulated after manufacturing and sales, In addition to grasping background information on patients using this drug, collect data on the safety and efficacy of this drug as soon as possible and take necessary measures for proper use of this drug.
About malignant melanoma
A malignant black specimen is a type of skin cancer, a malignant tumor that is cancerous of pigment cells (melanocytes) having the ability to produce melanin pigment, which is closely related to the color of the skin, has a high metastatic rate among skin cancers, It is considered highly malignant. It is reported that the number of malignant black species in Japan is about 4,000 (Note 2), and about 700 people (* 3) per year die from malignant black species. Especially in case of radical malignant melanoma with radical metastasis, 5-year survival rate is around 10%, poor prognosis.