Tag Archives: Susan Galbraith

AstraZeneca’s Imfinzi Granted Priority Review by FDA for Groundbreaking Perioperative Immunotherapy in Bladder Cancer

(IN BRIEF) AstraZeneca’s Imfinzi (durvalumab) has been granted Priority Review by the FDA for the treatment of muscle-invasive bladder cancer (MIBC), potentially becoming the first perioperative immunotherapy in this curative-intent setting. Supported by results from the NIAGARA Phase III trial, … Read the full press release

AstraZeneca’s Tagrisso Receives EU Recommendation as First Targeted Therapy for Unresectable EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) has been recommended for approval in the EU for treating adult patients with unresectable, locally advanced non-small cell lung cancer (NSCLC) with EGFR mutations who have not experienced disease progression after platinum-based chemoradiation therapy. This … 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

AstraZeneca to Present Key Cancer Research Breakthroughs at WCLC and ESMO 2024

(IN BRIEF) AstraZeneca will present significant cancer research at the 2024 World Conference on Lung Cancer (WCLC) and the European Society for Medical Oncology (ESMO) Congress. Highlights include new data on the effectiveness of Imfinzi in bladder cancer, a novel … Read the full press release

AstraZeneca Unveils Groundbreaking Advances in Cancer Care at ASCO 2024

(IN BRIEF) AstraZeneca is set to revolutionize cancer care with a slew of groundbreaking data presentations at the American Society of Clinical Oncology (ASCO) Annual Meeting. Over 100 abstracts will showcase 25 approved and potential new medicines, including two late-breaking … 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’s Truqap Receives EU Recommendation for ER-Positive Breast Cancer Treatment

(IN BRIEF) AstraZeneca’s Truqap, in combination with Faslodex, has received a positive recommendation from the European Medicines Agency (EMA) for treating estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast cancer with specific genetic alterations. The recommendation follows promising results from … Read the full press release

AstraZeneca’s Imfinzi Shows Promising Results in Phase III Trial for Small Cell Lung Cancer

(IN BRIEF) AstraZeneca announces positive outcomes from the ADRIATIC Phase III trial, revealing that its immunotherapy drug Imfinzi (durvalumab) demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) among patients with limited-stage small cell lung cancer (LS-SCLC) … 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

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’s Tagrisso Shows Promise in Phase III LAURA Trial for EGFR-Mutated Lung Cancer

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) demonstrates significant improvement in progression-free survival (PFS) for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) in the LAURA Phase III trial. The trial, led by Dr. Suresh Ramalingam, … Read the full press release

AstraZeneca Advances in Cell Therapy with Acquisition of Gracell Biotechnologies

(IN BRIEF) AstraZeneca has announced its definitive agreement to acquire Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases. This strategic move aims to bolster AstraZeneca’s presence in the field of … Read the full press release

AstraZeneca’s Imfinzi Combination Therapy Shows Promise in Phase III Trial for Liver Cancer Treatment

(IN BRIEF) AstraZeneca has reported positive high-level results from the EMERALD-1 Phase III trial, demonstrating that its drug Imfinzi (durvalumab), in combination with transarterial chemoembolisation (TACE) and bevacizumab, significantly improves progression-free survival (PFS) in patients with hepatocellular carcinoma (HCC) eligible … Read the full press release

AstraZeneca’s Tagrisso + Chemotherapy Granted Priority Review for EGFR-Mutated Lung Cancer Treatment in the US

(IN BRIEF) AstraZeneca’s supplemental New Drug Application (sNDA) for Tagrisso (osimertinib) in combination with chemotherapy has been granted Priority Review by the US Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced or metastatic epidermal … Read the full press release

AstraZeneca Presents Promising Data from Phase III Trials Advancing Cancer Treatments at ESMO Congress

(IN BRIEF) AstraZeneca has unveiled data from four pivotal Phase III trials at the European Society for Medical Oncology (ESMO) Congress, demonstrating advances in cancer treatments across multiple types of cancers. These trials include TROPION-Lung01 and TROPION-Breast01, showcasing the significance … Read the full press release

AstraZeneca Showcases Promising Advances in Lung Cancer Treatments at IASLC Conference 2023

(IN BRIEF) AstraZeneca is advancing its lung cancer portfolio at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer. The company is aiming to have an AstraZeneca medicine for over half of all … Read the full press release

FDA Accepts AstraZeneca’s NDA for Capivasertib Combination Therapy in Advanced Breast Cancer

(IN BRIEF) AstraZeneca’s new drug application (NDA) for capivasertib, in combination with Faslodex, has been accepted and granted Priority Review by the US FDA for the treatment of advanced breast cancer. The NDA is being reviewed under Project Orbis, which … Read the full press release

AstraZeneca showcases potential of Imfinzi-based treatment for early-stage lung cancer

(IN BRIEF) AstraZeneca will showcase new data from its industry-leading Oncology pipeline and portfolio at the American Association for Cancer Research Annual Meeting. A total of 70 presentations will be given, including a plenary presentation on the AEGEAN Phase III … Read the full press release

AstraZeneca: Exciting ROpel Phase III trial results demonstrate the potential for Lynparza with abiraterone to become a new 1st-line option for patients with metastatic castration-resistant prostate cancer

(PRESS RELEASE) CAMBRIDGE, 24-Sep-2021 — /EuropaWire/ — AstraZeneca (LSE/STO/Nasdaq: AZN), a British–Swedish multinational pharmaceutical and biopharmaceutical company, has announced positive high-level results from the PROpel Phase III trial showed AstraZeneca and MSD’s Lynparza (olaparib) in combination with abiraterone demonstrated a … Read the full press release