Welcome to our dedicated page for Astrazeneca Plc news (Ticker: AZN), a resource for investors and traders seeking the latest updates and insights on Astrazeneca Plc stock.
AstraZeneca PLC (AZN) generates a steady flow of news driven by its global biopharmaceutical activities in Oncology, Rare Diseases and BioPharmaceuticals. Company announcements frequently cover clinical trial milestones, regulatory decisions, manufacturing investments and strategic collaborations, offering investors and healthcare professionals insight into how its pipeline and marketed medicines are evolving.
Recent news highlights include multiple updates on Enhertu (trastuzumab deruxtecan) and Datroway (datopotamab deruxtecan), two antibody drug conjugates jointly developed with Daiichi Sankyo. These stories describe new Phase 3 trials, Breakthrough Therapy Designations, and approvals in indications such as HER2-positive early breast cancer, metastatic breast cancer, HER2-expressing endometrial cancer and HER2-expressing ovarian cancer, as well as TROP2-directed approaches in lung and breast cancer.
News items also cover immuno-oncology developments with Imfinzi (durvalumab), including perioperative regimens for gastric and gastroesophageal junction cancers based on the MATTERHORN trial, and broader use in gastrointestinal and thoracic malignancies. In Rare Diseases and immunology, AstraZeneca reports on approvals for Koselugo in adult NF1-associated plexiform neurofibromas and on expanded administration options for Saphnelo in systemic lupus erythematosus.
Beyond clinical and regulatory updates, AstraZeneca’s news feed includes information on large-scale manufacturing investments in the United States, such as expansion of biologics facilities in Maryland, and technology partnerships like the selection of Salesforce’s Agentforce Life Sciences platform for AI-powered customer engagement. Visitors to this AZN news page can review these developments to understand how AstraZeneca’s pipeline, approvals and infrastructure may influence its long-term strategic direction.
AstraZeneca and Daiichi Sankyo have initiated the TROPION-Lung12 Phase 3 trial, dosing their first patient to evaluate DATROWAY® (datopotamab deruxtecan) plus rilvegostomig or rilvegostomig monotherapy versus standard of care. The trial targets patients with stage 1 adenocarcinoma non-small cell lung cancer (NSCLC) after complete surgical resection who are ctDNA-positive or have high-risk pathological features.
Currently, stage 1 NSCLC treatment involves tumor resection, but up to 40% of patients may experience disease recurrence. While observation typically follows resection, adjuvant chemotherapy and/or immunotherapy may be offered to high-risk stage 1b patients. The trial aims to explore DATROWAY's potential role in combination with immunotherapy as an adjuvant treatment to prevent disease recurrence.
ENHERTU has received FDA approval for treating adult patients with unresectable or metastatic hormone receptor-positive, HER2-low or HER2-ultralow breast cancer that has progressed after endocrine therapies. The approval was based on the DESTINY-Breast06 Phase III trial, which demonstrated ENHERTU's superiority over chemotherapy with a median progression-free survival of 13.2 months versus 8.1 months.
The trial showed a 36% reduction in disease progression or death risk compared to chemotherapy, with a confirmed objective response rate of 62.6% for ENHERTU versus 34.4% for chemotherapy. The safety profile remained consistent with previous trials, with no new concerns identified. This approval expands ENHERTU's availability to an earlier HR-positive treatment setting and broadens the eligible patient population to include those with HER2-ultralow disease.
ENHERTU® has received FDA approval as the first HER2-directed therapy for patients with HER2 low or HER2 ultralow metastatic breast cancer who experienced disease progression after endocrine therapy. The approval is based on the DESTINY-Breast06 phase 3 trial, where ENHERTU showed:
- 36% reduction in disease progression or death risk vs chemotherapy
- Median progression-free survival of 13.2 months vs 8.1 months with chemotherapy
- 62.6% objective response rate vs 34.4% with chemotherapy
- 14.3 months median duration of response vs 8.6 months with chemotherapy
The drug, jointly developed by Daiichi Sankyo and AstraZeneca, received Priority Review and Breakthrough Therapy Designation. Following this approval, AstraZeneca will pay Daiichi Sankyo a $175 million milestone payment.
DATROWAY® (datopotamab deruxtecan-dlnk) has received FDA approval for treating adult patients with unresectable or metastatic HR positive, HER2 negative breast cancer who have previously received endocrine-based therapy and chemotherapy. The approval is based on the TROPION-Breast01 phase 3 trial results, which demonstrated:
- 37% reduction in disease progression or death risk versus chemotherapy
- Median progression-free survival of 6.9 months vs 4.9 months with chemotherapy
- Objective response rate of 36% vs 23% with chemotherapy
- Median duration of response of 6.7 months vs 5.7 months with chemotherapy
DATROWAY, jointly developed by Daiichi Sankyo and AstraZeneca, is the second DXd antibody drug conjugate approved in the U.S. The drug will be available by prescription in approximately two weeks.
DATROWAY® (datopotamab deruxtecan-dlnk) has received FDA approval for treating adult patients with unresectable or metastatic HR-positive, HER2-negative breast cancer who have received prior endocrine-based therapy and chemotherapy. The approval was based on the TROPION-Breast01 Phase III trial results, which showed a 37% reduction in the risk of disease progression or death compared to chemotherapy.
The trial demonstrated a median progression-free survival of 6.9 months for DATROWAY versus 4.9 months with chemotherapy. The safety profile was consistent with known data, with an interstitial lung disease rate of 4.2%, mostly low grade. This marks AstraZeneca's eighth new medicine of their targeted 20 medicines by 2030.
AstraZeneca's CALQUENCE (acalabrutinib) in combination with bendamustine and rituximab has received FDA approval for treating previously untreated mantle cell lymphoma (MCL) in adult patients ineligible for autologous stem cell transplantation. The approval was based on the ECHO Phase III trial results, which demonstrated a 27% reduction in disease progression or death risk compared to standard chemoimmunotherapy.
The trial showed median progression-free survival of 66.4 months for the CALQUENCE combination versus 49.6 months with chemoimmunotherapy alone. After censoring COVID-19 deaths, the risk reduction improved to 36%. This makes CALQUENCE the first and only BTK inhibitor approved for first-line MCL treatment in the US.
MCL is a rare and aggressive form of non-Hodgkin lymphoma, with over 21,000 patients diagnosed across major markets. The safety profile was consistent with known data, and no new safety signals were identified.
AstraZeneca and Daiichi Sankyo have received Priority Review from the FDA for datopotamab deruxtecan (Dato-DXd) in treating adult patients with advanced EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior therapies. The FDA decision is expected in Q3 2025.
The application is supported by data from multiple trials, including TROPION-Lung05, which showed a 42.7% objective response rate and a median duration of response of 7.0 months in previously treated patients. The drug previously received Breakthrough Therapy Designation for this indication.
If approved, datopotamab deruxtecan would become the first TROP2-directed antibody drug conjugate for lung cancer. The companies are currently conducting seven Phase III trials evaluating the drug alone and in combinations for NSCLC treatment.
AstraZeneca (AZN) and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) has received Priority Review status from the FDA for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior therapies. The FDA's decision date is set for July 12, 2025.
The application is supported by data from multiple clinical trials, including TROPION-Lung05 phase 2, TROPION-Lung01 phase 3, and TROPION-PanTumor01 phase 1. A pooled analysis presented at ESMO Asia 2024 showed clinically meaningful tumor response, with a safety profile consistent with previous reports.
Dato-DXd, a TROP2 directed antibody drug conjugate, could become the first of its kind approved for lung cancer. The drug is currently being evaluated in seven phase 3 trials, including combinations with osimertinib for EGFR-mutated nonsquamous NSCLC.
Asher Biotherapeutics has entered into a clinical supply agreement with AstraZeneca (AZN) for a global Phase 1b/2 study. The study will evaluate the combination of Asher Bio's etakafusp alfa (AB248) with AstraZeneca's rilvegostomig as a first-line treatment for advanced or metastatic non-small cell lung cancer (NSCLC).
Under the agreement, AstraZeneca will sponsor and conduct the global study, while Asher Bio will retain full ownership of etakafusp alfa and provide it at no cost. Initial Phase 1 data for etakafusp alfa has shown promising results, demonstrating selective CD8+ T cell activation and early evidence of anti-tumor effects, including confirmed objective responses.
AstraZeneca (AZN) and Daiichi Sankyo have voluntarily withdrawn their marketing authorization application (MAA) in the EU for datopotamab deruxtecan (Dato-DXd) for treating advanced nonsquamous non-small cell lung cancer (NSCLC). The withdrawal follows feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use.
The companies remain committed to developing the drug for lung cancer patients through seven pivotal trials. Their separate application for datopotamab deruxtecan in hormone receptor positive, HER2 negative metastatic breast cancer remains under EU review.
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