Daiichi and AstraZeneca cancer drugs secure further approvals in Japan
(Alliance News) - Daiichi Sankyo Co Ltd on Wednesday said that its breast cancer drugs, Enhertu and Datroway, which are being developed in partnership with AstraZeneca PLC, have been approved for new indications in Japan.
Tokyo-based pharmaceutical firm Daiichi discovered the drugs and is co‑commercialising them with Cambridge, England-based peer AstraZeneca, having entered agreements for Enhertu and Datroway in 2019 and 2020 respectively. Daiichi has retained exclusivity over both drugs in Japan.
It said that Enhertu, also known as trastuzumab deruxtecan, combined with pertuzumab, has been cleared for adults with HER2-positive unresectable or recurrent breast cancer.
Datroway, or datopotamab deruxtecan, has been cleared for adults with hormone receptor-negative and HER2-negative unresectable or recurrent breast cancer, also called triple-negative breast cancer.
The approval decisions come from Japan's Ministry of Health, Labour & Welfare, and are based on phase-three trial results.
Though both drugs are already approved in Japan, their approval comes with a warning against interstitial lung disease as a possible side effect, since ILD occurred in over 11% of patients given Enhertu and 3.1% of patients given Datroway, with some cases being fatal.
Besides Japan, the drugs have clearance across multiple territories for different cancer indications.
Daiichi Sankyo shares closed 0.1% higher at JPY2,839.00 on Wednesday in Tokyo. AstraZeneca traded 0.6% higher at 12,194.00 pence per share on Wednesday morning in London.
By Holly Munks, Alliance News reporter
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