AstraZeneca

FDA approves AstraZeneca's FluMist nasal spray flu vaccine for self-administration by adults up to 49 years or caregiver administration for ages 2-17, making it the only self-administered flu vaccine in the US. FluMist Home service will deliver vaccines to homes via an online pharmacy after a pharmacist review. FluMist remains available at medical offices and pharmacies.

AstraZeneca's cancer drug, datopotamab deruxtecan, failed to meet targets in a Phase 3 trial, jeopardizing U.S. FDA approval. Shares dropped 1.2%.

TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in overall survival (OS) analysis for inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative breast cancer patients, despite meeting progression-free survival (PFS) primary endpoint.

AstraZeneca's Fasenra recommended for EU approval as add-on treatment for EGPA, based on MANDARA trial results showing comparable remission rates to mepolizumab and higher OCS tapering success.

Fasenra recommended for approval in the EU by CHMP for EGPA treatment, supported by MANDARA trial showing 60% remission and 41% OCS cessation.

TROPION-Breast01 Phase III trial of datopotamab deruxtecan did not achieve statistical significance in overall survival (OS) analysis for inoperable or metastatic HR-positive, HER2-low or negative breast cancer patients, despite meeting progression-free survival (PFS) primary endpoint. Safety profile consistent with previous analysis, with no new safety concerns. Multiple ADCs approved during trial likely affected survival results. AstraZeneca and Daiichi Sankyo continue discussions with regulatory authorities and clinical development for datopotamab deruxtecan.

FDA approves home use of FluMist nasal spray flu vaccine for ages 2-49, offering convenience and accessibility. FluMist, containing weakened live influenza virus strains, requires prescription and can be self-administered by those 18+ or by caregivers for children 2-17. Common side effects include fever, nasal congestion, and sore throat.

FDA approves AstraZeneca's FluMist nasal spray flu vaccine for self-administration, available online next fall. Authorized for ages 2-49, it offers convenience and accessibility, potentially boosting vaccination rates.

Final overall survival results from TROPION-Breast01 Phase III trial of datopotamab deruxtecan (Dato-DXd) did not achieve statistical significance in HR-positive, HER2-low or negative breast cancer patients, despite positive progression-free survival results. Safety profile remained consistent with no new concerns. Subsequent treatment options likely affected survival results.

DelveInsight's 'HER2-mutant Non-Small Cell Lung Cancer Pipeline Insight 2024' covers 5+ companies and 5+ pipeline drugs, including clinical and nonclinical profiles, therapeutic assessments by product type, stage, route of administration, and molecule type, highlighting inactive products. Key companies include Dizal Pharmaceuticals, Puma Biotechnology, AstraZeneca, Jiangsu Hengrui Medicine, and Spectrum Pharmaceuticals Inc., with promising therapies like Trastuzumab deruxtecan and Poziotinib.