EU backs AstraZeneca, Daiichi's ENHERTU

EU backs AstraZeneca, Daiichi's Enhertu for breast cancer treatment post endocrine therapy
The European Union's health regulator on Friday backed AstraZeneca and Daiichi Sankyo's drug Enhertu as a breast cancer treatment for patients who received endocrine therapy but are not suitable for additional hormone treatments.
AstraZeneca, Daiichi Sankyo’s Enhertu recommended for approval in EU
AstraZeneca (AZN) and Daiichi Sankyo’s (DSNKY) trastuzumab deruxtecan has been recommended for approval in the European Union as a monotherapy
CHMP Recommends Approval of AstraZeneca, Daiichi Sankyo's Enhertu in HER2-Ultralow Breast Cancer
Approval would expand the use of Enhertu to breast cancer patients with nearly undetectable HER2 levels in their tumors.
AstraZeneca's metastatic breast cancer treatment gets EU recommendation
AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo said on Friday that the European Medicines Agency (EMA) endorsed ENHERTU for the treatment of metastatic breast cancer. Issuing a positive recommendation, EMA’s Committee for Medicinal Products for Human Use (CHMP)  recommended the marketing authorization for ENHERTUas a monotherapy for the treatment of
AstraZeneca Enhertu recommended for approval in EU by CHMP
Daiichi Sankyo and AstraZeneca’s Enhertu has been recommended for approval in the European Union as a monotherapy for the treatment of adult patients with unresectable or metast
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Daiichi Sankyo sees ENHERTU sales reaching ¥539.9B in FY2024 amid oncology momentum
Analysts flagged concerns over achieving oncology revenue targets amid dependency on ENHERTU’s growth to offset Datroway’s shortfall. Daiichi Sankyo’s Q3 FY2024 results reflect strong ...
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Daiichi Sankyo partners Alteogen on subcutaneous Enhertu
Daiichi Sankyo has signed a deal worth up to $300 million with South Korean biotech Alteogen to develop a subcutaneous version of its AstraZeneca-partnered cancer drug Enhertu. Alteogen will ...
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FDA Approves AstraZeneca And Daiichi Sankyo's ENHERTU For HER2-Low/Ultralow Breast Cancer
(AZN.L, AZN) and Daiichi Sankyo's (DSKYF.PK) ENHERTU (fam-trastuzumab deruxtecan-nxki) for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive ...
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FDA Approves AstraZeneca, Daiichi Sankyo’s Enhertu for Unresectable or Metastatic Hormone Receptor-Positive, HER2-Low Breast Cancer
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, HER2-low, or HER2-ultralow metastatic breast cancer. The FDA has approved ...
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Seagen wins Enhertu patent dispute with Daiichi Sankyo
A US jury has decided that Daiichi Sankyo and AstraZeneca's breast cancer drug Enhertu infringes a patent held by US biotech Seagen, awarding almost $42 million in damages. Seagen claims ...
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Daiichi Sankyo Earnings: Results in Line, Enhertu Momentum Continues; Shares Undervalued
Narrow-moat Daiichi Sankyo’s third-quarter earnings were ... However, it depends on the continued momentum of Enhertu, which remains strong so far. We expect multiple key data readouts this ...
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FDA Expands Label of AZN's Enhertu for New Breast Cancer Indication
AstraZeneca AZN and partner Daiichi Sankyo announced that the FDA has approved the supplemental biologics license application (sBLA) seeking approval for expanded use of Enhertu (trastuzumab ...