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News about "Susan Galbraith"
EMA Committee Recommends Approval of AstraZeneca and Daiichi Sankyo's Enhertu Plus Pertuzumab
If approved, AstraZeneca and Daiichi Sankyo’s Enhertu plus pertuzumab would become first new treatment in the European Union (EU) in more than a decade for first-line HER2-positive metastatic breast cancer.
Susan Galbraith | 25/07/2026 | By News Bureau
Camizestrant Plus CDK4/6 Inhibitor Recommended for EU Approval in Advanced ER-Positive Breast Cancer
Camizestrant plus a CDK4/6 inhibitor receives CHMP recommendation for EU approval in first-line advanced ER-positive breast cancer, supported by phase 3 SERENA-6 trial results showing a 56 percent reduction in disease progression or death.
Susan Galbraith | 25/05/2026 | By News Bureau | 154
US FDA Recommends AstraZeneca's TRUQAP for PTEN-Deficient Prostate Cancer
US Food and Drug Administration (FDA) advisory panel backs TRUQAP (capivasertib) with abiraterone and ADT for PTEN-deficient metastatic hormone-sensitive prostate cancer, based on positive phase 3 CAPItello-281 results showing favorable benefit-risk.
Susan Galbraith | 01/05/2026 | By News Bureau
Imfinzi Combo Improves PFS in Unresectable Liver Cancer in Phase 3 EMERALD-3 Trial
Imfinzi-based combination improves progression-free survival and shows a trend towards overall survival benefit in unresectable liver cancer in the Phase 3 EMERALD-3 trial.
Susan Galbraith | 04/04/2026 | By News Bureau | 107
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 | 205
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 | 207
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 | 177
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 | 210
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