News releases from AstraZeneca
BYDUREON BCise (exenatide extended-release) Approved in the US for the Treatment of Type 2 Diabetes in Pediatric Patients Ages 10 Years and Older
July 23, 2021
AstraZeneca’s BYDUREON BCise (exenatide extended-release), once-weekly injectable suspension has been approved in the US for the treatment of type 2 diabetes (T2D); to improve glycemic control in...
Tezepelumab Regulatory Submission Accepted and Granted FDA Priority Review in the US for the Treatment of Patients with Asthma
July 08, 2021
AstraZeneca’s Biologics License Application (BLA) for tezepelumab has been accepted and granted Priority Review for the treatment of asthma from the US Food and Drug Administration (FDA). Tezepelumab...
Phase III pivotal trial of once weekly exenatide in adolescents aged 10–17 shows benefit for the treatment of type 2 diabetes
June 25, 2021
Positive results from the Phase III pivotal trial (NCT01554618) showed AstraZeneca’s exenatide extended-release 2mg once weekly significantly reduced blood sugar—as measured by HbA1c—versus placebo in...
CALQUENCE Demonstrated Fewer Incidences of Atrial Fibrillation Versus Ibrutinib in Previously Treated Patients With Chronic Lymphocytic Leukemia and Sustained Patient Benefit at Four Years in the Fron
June 07, 2021
Final results from the head-to-head ELEVATE-RR Phase III trial of AstraZeneca’s CALQUENCE (acalabrutinib) demonstrated non-inferior progression-free survival (PFS) and statistically significantly fewer...
IMFINZI Demonstrated Unprecedented Survival in Unresectable Stage III Lung Cancer With 43% Of Patients Surviving Five Years
June 04, 2021
Updated results from the positive PACIFIC Phase III trial showed AstraZeneca’s IMFINZI® (durvalumab) demonstrated a sustained, clinically meaningful overall survival (OS) and progression-free survival...
LYNPARZA® (olaparib) reduced the risk of cancer recurrence by 42% in the adjuvant treatment of patients with germline BRCA-mutated high-risk early breast cancer in OlympiA Phase III trial
June 03, 2021
AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, today announced results from the OlympiA Phase III trial showed LYNPARZA® (olaparib) demonstrated a statistically significant...
AstraZeneca ASCO 2021 Data Support Ambition to Revolutionize Cancer Outcomes by Treating Earlier and Transforming the Patient Experience
May 19, 2021
AstraZeneca will present new data underscoring its ambition to redefine cancer care at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 4 to 8, 2021.
New FASENRA® Data From the MELTEMI Extension Trial Confirm Long-Term Safety and Efficacy in Severe Eosinophilic Asthma for up to Five Years
May 19, 2021
Results from a new integrated analysis including data from the MELTEMI Phase III open-label extension trial showed FASENRA® (benralizumab) was well-tolerated for up to five years, with a long-term...
New Tezepelumab Data Continue to Strengthen Profile for a Broad Population of Severe Asthma Patients
May 13, 2021
Detailed results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen’s tezepelumab, a potential first-in-class treatment, demonstrated superiority across every primary and key...
IMFINZI and tremelimumab With Chemotherapy Demonstrated Overall Survival Benefit in POSEIDON Trial for 1st-line Stage IV Non-small Cell Lung Cancer
May 07, 2021
POSEIDON was a Phase III trial of AstraZeneca’s IMFINZI® (durvalumab) plus platinum-based chemotherapy or IMFINZI, tremelimumab and chemotherapy versus chemotherapy alone in the 1st-line treatment of...
FARXIGA Approved in the US for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type 2 Diabetes
April 30, 2021
AstraZeneca’s FARXIGA® (dapagliflozin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor, has been approved in the US to reduce the risk of sustained estimated glomerular filtration rate (eGFR)...
AstraZeneca Announces Collaboration with Massachusetts General Hospital to Accelerate Digital Health Solutions
April 06, 2021
AstraZeneca has entered into a collaboration agreement with Massachusetts General Hospital (MGH), leveraging robust data and clinical best practices to create digital health solutions that address...
Positive high-level results from the primary analysis of the Phase III trial of AZD1222 in the US have confirmed vaccine efficacy consistent with the pre-specified interim analysis announced on Monday,...
AZD1222 US Phase III Trial Met Primary Efficacy Endpoint in Preventing COVID-19 at Interim Analysis
March 22, 2021
The AstraZeneca US Phase III trial of AZD1222 demonstrated statistically significant vaccine efficacy of 79% at preventing symptomatic COVID-19 and 100% efficacy at preventing severe disease and...
Tezepelumab Is the First Biologic to Consistently and Significantly Reduce Exacerbations in Broad Population of Severe Asthma Patients
February 26, 2021
Positive full results from the pivotal NAVIGATOR Phase III trial showed AstraZeneca and Amgen’s tezepelumab demonstrated a statistically significant and clinically meaningful1 reduction in the...
IDMC has Concluded that OlympiA Trial of LYNPARZA® (olaparib) Crossed Superiority Boundary for Invasive Disease-free Survival Vs. Placebo at Planned Interim Analysis
February 17, 2021
AstraZeneca and Merck & Co., Inc., known as MSD outside the US and Canada, today announced the OlympiA Phase III trial for LYNPARZA® (olaparib) will move to early primary analysis and reporting...
TAGRISSO Extended Disease-Free Survival Regardless of Prior Adjuvant Chemotherapy in Early-Stage EGFR-Mutated Lung Cancer
January 29, 2021
Results from an exploratory analysis of the positive ADAURA Phase III trial showed AstraZeneca’s TAGRISSO® (osimertinib) extended disease-free survival (DFS) in patients with epidermal growth factor...
CALQUENCE Met Primary Efficacy Endpoint in Head-to-Head Trial Against ibrutinib in Chronic Lymphocytic Leukemia
January 25, 2021
Positive high-level results from the ELEVATE-RR Phase III trial showed AstraZeneca’s CALQUENCE® (acalabrutinib) met the primary endpoint demonstrating non-inferior progression-free survival (PFS) for...
ENHERTU® (fam-trastuzumab deruxtecan-nxki) Approved in the US for the Treatment of Patients with Previously Treated HER2-Positive Advanced Gastric Cancer
January 18, 2021
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) has been approved in the US for the treatment of adult patients with locally advanced or...
AstraZeneca to Showcase Transformative Data Across Diverse Pipeline at World Conference on Lung Cancer
January 13, 2021
AstraZeneca will present new data from across the innovative lung cancer portfolio at the IASLC 2020 World Conference on Lung Cancer (WCLC), hosted by the International Association for the Study of...
FARXIGA Granted Priority Review in the US for the Treatment of Patients With Chronic Kidney Disease
January 06, 2021
AstraZeneca’s FARXIGA (dapagliflozin) has been granted Priority Review in the US for the treatment of new or worsening chronic kidney disease (CKD) in adults with and without type 2 diabetes (T2D).
ADDING MULTIMEDIA TAGRISSO Approved in the US for the Adjuvant Treatment of Patients With Early-Stage EGFR-mutated Lung Cancer
December 21, 2020
AstraZeneca’s TAGRISSO® (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung...
ENHERTU (fam-trastuzumab deruxtecan-nxki) Continues to Demonstrate Durable Responses with New Data From DESTINY-Breast01 in HER2-positive Metastatic Breast Cancer
December 10, 2020
Updated results from the positive DESTINY-Breast01 Phase II trial showed AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s ENHERTU® (fam-trastuzumab deruxtecan-nxki) continued to...
CORRECTING and REPLACING CALQUENCE Shows Long-Term Efficacy and Tolerability at Three Years for Patients With Relapsed or Refractory Mantle Cell Lymphoma
December 07, 2020
In the release that dated December 6, 2020, the "Summary of efficacy results" table should appear as follows:
CALQUENCE Data Across Four Trials Reinforces Cardiovascular Safety Profile in Patients With Chronic Lymphocytic Leukemia
December 07, 2020
A pooled analysis of cardiovascular (CV) safety data from 762 patients treated with CALQUENCE® (acalabrutinib) monotherapy for chronic lymphocytic leukemia (CLL), the most common type of adult...
AstraZeneca Demonstrates Growing Leadership in Breast Cancer at SABCS with Data From Its Innovative Medicines and Robust Pipeline
December 03, 2020
AstraZeneca will unveil new developments across a range of stages and subtypes of breast cancer at the 2020 San Antonio Breast Cancer Symposium (SABCS), which will be held virtually from 8 to 11...
AstraZeneca’s IMFINZI® (durvalumab) has been approved in the US for an additional dosing option, a 1,500mg fixed dose every four weeks, in the approved indications of unresectable Stage III non-small...
AstraZeneca will present new research aimed at addressing key unmet needs facing patients with blood cancers at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, held...
Data from contemporary registry confirms that four out of five patients with heart failure with reduced ejection fraction eligible for treatment with FARXIGA
November 13, 2020
New data from a large, contemporary US hospitalized heart failure (HF) registry confirms that four out of five (81.1%) patients with NYHA class II-IV HF with reduced ejection fraction (HFrEF), with and...
Tezepelumab NAVIGATOR Phase III Trial Met Primary Endpoint of a Statistically Significant and Clinically Meaningful Reduction in Exacerbations in a Broad Population of Patients With Severe Asthma
November 10, 2020
AstraZeneca and Amgen today announced positive results from the NAVIGATOR Phase III trial for the potential new medicine tezepelumab in patients with severe, uncontrolled asthma.