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News about "Susan Galbraith"
The FDA has granted Priority Review to Datroway for first-line treatment of metastatic triple-negative breast cancer patients ineligible for immunotherapy, with a regulatory decision expected in Q2 2026.
Susan Galbraith | 04/02/2026 | By News Bureau
CHMP Recommends Imfinzi for Early Gastric Cancers
The EU’s CHMP has recommended approval of AstraZeneca’s Imfinzi perioperative regimen for early gastric and gastroesophageal cancers following positive phase-III MATTERHORN data, showing a 29 percent reduction in progression or recurrence risk and a 22 percent reduction in mortality versus chemotherapy alone.
Susan Galbraith | 04/02/2026 | By News Bureau
Enhertu Secures US BTD Status in Early HER2-Positive Breast Cancer
The US FDA has granted Breakthrough Therapy Designation to Enhertu for use as post-neoadjuvant treatment in patients with HER2-positive early breast cancer, marking the tenth such designation for AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate, supported by phase III DESTINY-Breast05 trial results.
Susan Galbraith | 23/12/2025 | By News Bureau
US FDA Grants Priority Review for Enhertu + Pertuzumab in HER2+ Metastatic Breast Cancer
The US FDA has granted Priority Review to Enhertu + Pertuzumab for HER2+ metastatic breast cancer, following DESTINY-Breast09 trial results showing a 44 percent reduction in risk of disease progression or death and over three years’ median Progression-Free Survival (PFS), positioning it as a potential new first-line standard of care.
Susan Galbraith | 25/09/2025 | By Dineshwori | 111
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