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AstraZeneca-Daiichi Sankyo Enhertu gets USFDA Breakthrough Therapy Designation in HER2-positive early breast cancer
22 Dec 2025 12:56 GMT
… Designation highlights the impressive clinical benefit of Enhertu over the current … , Global Head, R&D, Daiichi Sankyo, said, “This tenth Breakthrough Therapy … drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and …
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<![CDATA[Breast Cancer Data Affirm Aromatase Inhibitors as Optimal Endocrine Therapy]]>
24 Dec 2025 00:31 GMT
… analyses showed that this DFS benefit persisted regardless of patient characteristics … did not observe an additional benefit of adding OFS… to SERM … Pharmaceuticals, Ipsen, Sandoz, Libbs, and Daiichi Sankyo.
References
Lambertini M, Samy F …
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Continued Scrutiny of Genus Claims: The Written Description and Enablement Requirements for Broad and Previously Undisclosed Subgenera
23 Dec 2025 18:59 GMT
… , an ADC, manufactured by Daiichi Sankyo (Daiichi), containing a tetrapeptide … the innovation for public benefit and use upon expiration … owner to obtain the benefit of an exclusive right … applications.
1Seagen Inc. v. Daiichi Sankyo Co., Ltd., 2023-2424 ( …
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<![CDATA[FDA Grants Breakthrough Status to Enhertu for Some HER2+ Early Breast Cancers ]]>
23 Dec 2025 16:30 GMT
… release from AstraZeneca.
AstraZeneca and Daiichi Sankyo’s Enhertu's breakthrough … designation highlights the impressive clinical benefit of Enhertu over the current … , Global Head, R&D, Daiichi Sankyo, said: “This tenth breakthrough therapy …
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<![CDATA[FDA Gives Breakthrough Therapy Designation to Post-Neoadjuvant T-DXd for HER2+ Early Breast Cancer]]>
22 Dec 2025 21:35 GMT
… of R&D at Daiichi Sankyo, stated in a news release … designation highlights the impressive clinical benefit of [T-DXd] over the …
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<![CDATA[T-DXd Granted Breakthrough Therapy Designation in Post-Neoadjuvant HER2-Positive Early Breast Cancer]]>
22 Dec 2025 20:45 GMT
… deruxtecan-nxki (T-DXd, Enhertu; Daiichi Sankyo, Inc., AstraZeneca), an antibody-drug … supporting T-DXd’s clinical benefit across multiple stages of HER2 … , and counseling patients on expected benefits and potential toxicities. T-DXd …
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<![CDATA[FDA Grants Breakthrough Therapy Designation to T-DXd Early HER2+ BC]]>
22 Dec 2025 16:55 GMT
… met, showing a robust clinical benefit for T-DXd over T … of Research and Development at Daiichi Sankyo, in a news release.
REFERENCES …
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ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Breakthrough Therapy Designation in the US as post-neoadjuvant therapy for patients with HER2-positive early breast cancer
22 Dec 2025 14:17 GMT
… Designation highlights the impressive clinical benefit of ENHERTU over the … verification and description of clinical benefit in a confirmatory trial.
… HER2-targetable cancers.
Daiichi Sankyo collaboration
AstraZeneca and Daiichi Sankyo entered into a global …
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Global Precision Medicine Market Growth Accelerates at 16.26% CAGR Through 2035 Expands Rapidly as AI, Genomic Testing, and Targeted Therapies Gain Momentum
22 Dec 2025 15:03 GMT
… infants
Radioligand therapy showed PFS benefit in earlier-stage prostate cancer … in drug discovery
Healthcare providers benefit from improved outcomes and data …
$8.3 Billion
Datopotamab Deruxtecan
Daiichi Sankyo / AstraZeneca
Lung & Breast …
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AstraZeneca gets fresh designation for Enhertu while Imfinzi trial fizzles
22 Dec 2025 10:11 GMT
… designation highlights the impressive clinical benefit of Enhertu over the current … in the post-neoadjuvant setting.”
Daiichi Sankyo’s global head of research … antibody-drug conjugate discovered by Daiichi Sankyo and jointly developed and commercialised …
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