EMA validates EU Type II variation application for Daiichi Sankyo’s Enhertu in HER2-positive early breast cancer

Reuters

Feb 19

EMA validates EU Type II variation application for <a href="https://laohu8.com/S/DSKY">Daiichi Sankyo</a>’s Enhertu in HER2-positive early breast cancer

The European Medicines Agency has validated a Type II Variation application for ENHERTU (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant HER2-targeted treatment. The validation confirms the application is complete and initiates scientific review by the EMA’s Committee for Medicinal Products for Human Use; ENHERTU is jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Daiichi Sankyo Co. Ltd. published the original content used to generate this news brief via Business Wire (Ref. ID: 202602190230BIZWIRE_USPR_____20260218_BW497698) on February 19, 2026, and is solely responsible for the information contained therein.

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The validation confirms the application is complete and initiates scientific review by the EMA’s Committee for Medicinal Products for Human Use; ENHERTU is jointly developed and commercialized by <a href=\"https://laohu8.com/S/DSKYF\">Daiichi Sankyo</a> and AstraZeneca.\n      </p>\n</div><div xmlns:xsd=\"http://www.w3.org/2001/XMLSchema\" xmlns:xsi=\"http://www.w3.org/2001/XMLSchema-instance\">\n<p>\n<i>Disclaimer: <span>This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Daiichi <a href=\"https://laohu8.com/S/SKXJF\">Sankyo Co. Ltd.</a> published the original content used to generate this news brief via Business Wire (Ref. 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The validation confirms the application is complete and initiates scientific review by the EMA’s Committee for Medicinal Products for Human Use; ENHERTU is jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.\n      \n\n\nDisclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Daiichi Sankyo Co. Ltd. published the original content used to generate this news brief via Business Wire (Ref. 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