AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. The decision marks the first global marketing approval for Evusheld as a treatment for COVID-19.
Today, new results from a pre-specified, patient level, pooled analysis from the Phase III DAPA-HF and DELIVER trials demonstrated mortality benefit of Farxiga (dapagliflozin), compared to placebo, in patients with heart failure (HF). These results were presented at the European Society of Cardiology Congress 2022 in Barcelona, Spain and simultaneously published in Nature Medicine.
Detailed results from the DELIVER Phase III trial showed AstraZeneca’s Farxiga (dapagliflozin) significantly reduced the composite of cardiovascular (CV) death or worsening heart failure (HF) in patients with HF and mildly reduced or preserved ejection fraction (EF), compared to placebo.
Ultomiris (ravulizumab) has been approved in Japan for the treatment of adult patients with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control with high-dose intravenous immunoglobulin therapy (IVIg) or plasmaphaeresis.
AstraZeneca’s Tagrisso (osimertinib) has been approved in Japan for the adjuvant treatment of patients with epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after surgery. This approval by the Japanese Ministry of Health, Labour and Welfare was based on positive results from the global ADAURA Phase III trial.
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the adjuvant treatment of patients with BRCA-mutated (BRCAm), HER2-negative early breast cancer at high risk of recurrence.
AstraZeneca will present new data supporting its ambition to redefine cancer care at the European Society for Medical Oncology (ESMO) Congress 2022, 9 to 13 September 2022. A total of 15 approved and potential new medicines from AstraZeneca will be featured across more than 75 abstracts in 13 tumour types.
AstraZeneca’s supplemental New Drug Application (sNDA) for Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been accepted and granted Priority Review in the US for the treatment of adult patients with metastatic castration-resistant prostate cancer (mCRPC).
Positive high-level results from the DESTINY-Breast02 Phase III trial of Enhertu versus physician’s choice of treatment showed the trial met the primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival in patients with HER2-positive unresectable and/or metastatic breast cancer previously treated with trastuzumab emtansine.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a Food and Drug Administration (FDA)-approved test, and who have received a prior systemic therapy.
AstraZeneca has completed the acquisition of TeneoTwo, Inc. (TeneoTwo)i, including its Phase I clinical-stage CD19/CD3 T-cell engager, TNB-486, currently under evaluation in relapsed and refractory B-cell non-Hodgkin lymphoma.1 AstraZeneca will develop TNB-486 as a potential new medicine for B-cell haematologic malignancies.
Initial results from the TROPION-Lung02 Phase Ib trial showed that datopotamab deruxtecan (Dato-DXd) in combination with pembrolizumab with or without platinum chemotherapy demonstrated promising clinical activity and a tolerable safety profile in patients with previously untreated or pretreated, advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.
Preliminary results from the SAVANNAH Phase II trial showed that Tagrisso (osimertinib) plus savolitinib demonstrated an objective response rate of 49% in patients with epidermal growth factor receptor-mutated non-small cell lung cancer with high levels of MET overexpression and/or amplification, defined as IHC90+ and/or FISH10+, whose disease progressed on treatment with Tagrisso.
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.
New formulation can be co-administered with gastric acid-reducing agents. Tablet offers equivalent efficacy, safety and consistent dosing compared to current capsule.
AstraZeneca’s new tablet formulation of Calquence (acalabrutinib) has been approved in the US for all current indications, including adult patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and for
First and only approved medicine targeting BRCA mutations in early breast cancer.AstraZeneca and MSD’s Lynparza (olaparib) has been approved in the European Union (EU) as monotherapy or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2 mutations (gBRCAm), who have human epidermal growth factor receptor 2 (HER2)-negative high-risk early breast
AstraZeneca PLC today announced the appointment of Michel Demaré as the Chair-designate of the Board.
Stark utveckling av intäkterna och framgång inom FoU möjliggör ytterligare investeringar i forskningsportföljen och nya lanseringar
Based on DESTINY-Breast04 results which showed AstraZeneca and Daiichi Sankyo’s Enhertu is the first HER2-directed therapy to demonstrate a survival benefit in this population. Application being evaluated under FDA Real-Time Oncology Review and Project Orbis.
AstraZeneca and Daiichi Sankyo have received notification of acceptance of the supplemental Biologics License Application (sBLA) of Enher
First and only biologic recommended for EU approval in patients with severe asthma with no phenotype or biomarker limitations.
AstraZeneca’s Tezspire (tezepelumab) has been recommended for marketing authorisation in the European Union (EU) as an add-on therapy in patients 12 years and older with severe asthma who are inadequately controlled with high dose inhaled corticosteroids plus another me