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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Enhertu role in breast cancer confirmed, as Daiichi wins Seagen dispute
AstraZeneca and Daiichi Sankyo have the confirmatory trial data they were hoping for with Enhertu as a treatment for advanced, HER2-positive breast cancer in previously-treated patients.
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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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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 ...
Pharm Exec1mon
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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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 ...
Business Wire29d
Daiichi Sankyo Appoints Hiroyuki Okuzawa as Chief Executive Officer
leading to three of the largest licensing deals in history along with the approvals of ENHERTU ® and DATROWAY ®, two precision cancer medicines invented with Daiichi Sankyo’s DXd ADC ...
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Daiichi Sankyo Company, Limited (DSKYF) Q3 2024 Earnings Call Transcript
In the Japan business unit, sales of Lixiana, a direct oral anticoagulant; Tarlige analgesic; and ENHERTU, an anti-cancer agent increased as did the sales of Daiichi Sankyo Healthcare, while ...