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Trastuzumab BS for I.V. Infusion 60mg “NK”・150mg “NK” Obtained Approval for Additional Dosage & Administration of Breast Cancer with HER2 Overexpression

2019/08/21

Tokyo, Japan, August 21, 2019 - 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 additional dosage & administration of breast cancer with HER2 overexpression 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. Then in November 2018, Nippon Kayaku obtained approval for additional indication of breast cancer with HER2 overexpression.

With obtained this approval, Nippon Kayaku expects to make a significant contribution to the patients, their families and medical professionals.


【Reference】
The underlined descriptions are newly added or changed.
Product nameTrastuzumab BS for I.V. Infusion 60mg “NK”
Trastuzumab BS for I.V. Infusion 150mg “NK”
Generic nameTrastuzumab(Genetical Recombination)[Trastuzumab Biosimilar 1]
IndicationsBreast cancer with HER2 overexpression
Advanced or recurrent gastric cancer with HER2 overexpression, not amenable to curative resection
Dosage and administrationRegimen A or Regimen B should be used for breast cancer with HER2 overexpression.
Regimen B should be used concomitantly with other anticancer drugs for advanced or recurrent gastric cancer overexpressing HER2, not amenable to curative resection.
Regimen A:
Usually for adults, an initial dose of 4 mg trastuzumab per kilogram body weight, and subsequent doses of 2 mg/kg, are administered as a single intravenous infusion over at least 90 minutes once a week.
Regimen B:
Usually for adults, an initial dose of 8 mg trastuzumab per kilogram body weight, and subsequent doses of 6 mg/kg, are administered as a single intravenous infusion over at least 90 minutes once every three weeks.
If the first infusion is well tolerated, the subsequent infusions may be shortened to 30 minutes.



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Telephone: +81- 3- 6731- 5237
Public Relations & Investor Relations Division
Nippon Kayaku Co., Ltd.
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