Trastuzumab BS for I.V. Infusion 60mg “NK”・150mg “NK” Obtained Approval for Additional Indication
2023/10/18Tokyo, Japan, October 18, 2023 - Nippon Kayaku Co., Ltd. (Head Office: Tokyo; President: Atsuhiro Wakumoto; hereinafter referred to as “Nippon Kayaku”) today announced that it obtained approval by the Japanese Ministry of Health, Labour and Welfare (MHLW), for the additional indication of advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy not amenable to curative resection for Trastuzumab BS for I.V. Infusion 60mg “NK” ・150mg “NK”(hereinafter referred to as Trastuzumab BS “NK”).
Trastuzumab BS “NK” is a biosimilar of the trastuzumab, humanized anti-human HER2 monoclonal antibody. In March 2018, Nippon Kayaku obtained the manufacture and marketing approval with the indication of unresectable advanced or recurrent gastric cancer with HER2 overexpression and has been marketing since August 2018. In November 2018, Nippon Kayaku obtained approval for additional indication of breast cancer with HER2 overexpression, and then in August 2019, got authorization for additional dosage & administration of breast cancer with HER2 overexpression．
Nippon Kayaku will strive to promote the proper use of this drug, provide information, and ensure a stable supply. In addition, we will promote the domestic development of biosimilars and strive to contribute to patients, their families, and medical professionals.
[Please direct inquiries regarding this matter to:]
Telephone: +81- 3- 6731- 5237
Corporate & Comunications Division
Nippon Kayaku Co., Ltd.