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AstraZeneca PLC (AZN) is a global biopharmaceutical leader focused on oncology, cardiovascular, respiratory, and immunology research. This centralized hub provides verified company announcements, press releases, and market-moving developments from authoritative sources.
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AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo announced that ENHERTU® in combination with pertuzumab has received Breakthrough Therapy Designation (BTD) from the FDA for first-line treatment of HER2 positive metastatic breast cancer.
The designation is based on data from the DESTINY-Breast09 phase 3 trial, which demonstrated a remarkable median progression-free survival of more than three years when using ENHERTU plus pertuzumab. This represents a significant improvement over the current standard of care that has been used for over a decade.
This marks ENHERTU's ninth BTD overall and fifth BTD for metastatic breast cancer, highlighting the drug's expanding potential in cancer treatment. It is also Daiichi Sankyo's thirteenth BTD across its oncology portfolio.
AstraZeneca (NYSE:AZN) announced positive Phase III trial results for baxdrostat, a potential first-in-class aldosterone synthase inhibitor for treating uncontrolled or treatment-resistant hypertension. The BaxHTN trial, involving 796 patients, demonstrated that both 2mg and 1mg doses achieved statistically significant and clinically meaningful reductions in systolic blood pressure compared to placebo at 12 weeks.
The trial successfully met its primary endpoint and all secondary endpoints, with baxdrostat showing a favorable safety profile. This breakthrough is particularly significant as 50% of US hypertensive patients on multiple treatments still struggle with blood pressure control, and globally, 1.3 billion people live with hypertension.
AstraZeneca (NYSE:AZN) has received US FDA approval for DATROWAY® (datopotamab deruxtecan-dlnk) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) who have received prior EGFR-directed therapy and platinum-based chemotherapy.
The approval, granted under accelerated approval based on objective response rate (ORR) of 45% and duration of response (DoR) of 6.5 months, follows Priority Review and Breakthrough Therapy Designation. DATROWAY becomes the first and only TROP2-directed therapy approved in the US for lung cancer treatment.
The safety profile was evaluated in 125 patients across multiple trials, with no new safety concerns identified. A milestone payment of $45 million is due from AstraZeneca to Daiichi Sankyo following this approval.
AstraZeneca (NYSE:AZN) and Daiichi Sankyo have received FDA approval for DATROWAY® (datopotamab deruxtecan-dlnk), marking it as the first TROP2 directed therapy for previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC). The approval is based on the TROPION-Lung05 phase 2 and TROPION-Lung01 phase 3 trials, where DATROWAY showed a 45% objective response rate with a median duration of response of 6.5 months.
The drug received Priority Review and Breakthrough Therapy Designation from the FDA. Following this approval, AstraZeneca will pay a $45 million milestone payment to Daiichi Sankyo. This marks DATROWAY's second U.S. approval in less than six months, with Daiichi Sankyo recognizing U.S. sales.