Tag Archives: Daiichi Sankyo

FDA Grants Priority Review for AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan has been accepted by the U.S. FDA for treating advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) in patients who have previously received systemic therapies. The … Read the full press release

Enhertu by AstraZeneca and Daiichi Sankyo Approved in China as First HER2-Directed Therapy for Metastatic Lung Cancer

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China for the treatment of patients with unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations who have previously undergone systemic … Read the full press release

AstraZeneca and Daiichi Sankyo’s Enhertu Receives Priority Review for HER2-Low and Ultralow Breast Cancer Patients Pre-Chemotherapy

(IN BRIEF) AstraZeneca and Daiichi Sankyo announced that their drug Enhertu (trastuzumab deruxtecan) has been granted Priority Review by the US FDA for treating patients with unresectable or metastatic HER2-low or HER2-ultralow breast cancer who have previously undergone endocrine therapy. … Read the full press release

Enhertu Gains Conditional Approval in China for Advanced HER2-Positive Gastric Cancer Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu has received conditional approval in China for treating locally advanced or metastatic HER2-positive gastric cancer, following promising results from the DESTINY-Gastric06 trial. This marks the third approval for Enhertu in China in less … Read the full press release

Positive Results from DESTINY-Breast06 Trial: Enhertu Shows Promise in HER2-Low and HER2-Ultralow Breast Cancer Patients

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu, a HER2-directed antibody drug conjugate (ADC), has demonstrated significant progress in treating HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. The high-level results from the DESTINY-Breast06 Phase … Read the full press release

AstraZeneca and Daiichi Sankyo’s BLA for Datopotamab Deruxtecan Accepted by FDA for Advanced Breast Cancer Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been acknowledged by the US FDA for treating adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior systemic … Read the full press release

What’s new in cancer care across Europe in early 2024 (1 Jan – 5 Mar 2024): Advancements, Innovations, Research, Awareness

(IN BRIEF) In early 2024, Europe’s medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for lung and breast cancer, and AstraZeneca’s Tagrisso for EGFR-mutated lung cancer. Diagnostic advancements … Read the full press release

EMA Validates Marketing Authorisation Applications for AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan in Lung and Breast Cancer Treatment

(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast … Read the full press release

AstraZeneca and Daiichi Sankyo’s Datopotamab Deruxtecan Moves Closer to Approval for Advanced NSCLC Treatment

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the FDA for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in patients who have undergone prior … Read the full press release

AstraZeneca and Daiichi Sankyo Gain EU Approval for Enhertu as Monotherapy for HER2-Mutant Lung Cancer

(IN BRIEF) AstraZeneca and Daiichi Sankyo have received European Union (EU) approval for their drug Enhertu as a monotherapy for the treatment of advanced non-small cell lung cancer (NSCLC) in adult patients with activating HER2 mutations who require systemic therapy … Read the full press release

Rare disease: Enhertu of AstraZeneca and Daiichi Sankyo now with Orphan Drug Designation in the US for treatment of gastric cancer

(PRESS RELEASE) CAMBRIDGE, 22-May-2020 — /EuropaWire/ — Enhertu, jointly developed by British-Swedish multinational pharmaceutical and biopharmaceutical company AstraZeneca and the second-largest pharmaceutical company in Japan Daiichi Sankyo (Daiichi Sankyo Company, Limited), has just been granted Orphan Drug Designation (ODD) in … Read the full press release