Nasdaq

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

Application based on DESTINY-Breast03 results showing Daiichi Sankyo and AstraZeneca’s trastuzumab deruxtecan reduced risk of disease progression or death by 72% versus trastuzumab emtansine (T-DM1) ...
Agence France-Presse

ENHERTU® Type II Variation Application Validated in the EU as Post-Neoadjuvant Treatment for Patients with HER2 Positive Early Breast Cancer

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU ® (trastuzumab deruxtecan) as a monotherapy for adult patients with HER2 ...
Yahoo Finance

DATROWAY® Type II Variation Application Validated in the EU as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who are Not Candidates for ...

TOKYO & MUNICH, December 18, 2025--(BUSINESS WIRE)--The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for DATROWAY ® (datopotamab deruxtecan) ...
Business Wire

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Low Metastatic Breast Cancer with HR Positive and HR Negative Disease

TOKYO & MUNICH--(BUSINESS WIRE)--Daiichi Sankyo (TSE: 4568) today announced that the European Medicines Agency (EMA) has validated the Type II Variation application for trastuzumab deruxtecan as ...
Nasdaq

European Medicines Agency Validates Type II Variation Application for PADCEV™ (enfortumab vedotin) with KEYTRUDA®(pembrolizumab) for First-Line Treatment of Advanced Bladder ...

TOKYO and NEW YORK, Jan. 26, 2024/ PRNewswire/-- Astellas Pharma Inc. and Pfizer Inc. today announced that on Jan. 26, 2024 the European Medicines Agency validated for review a Type II variation ...
Barron's

ENHERTU(R) Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

The European Medicines Agency (EMA) has validated the Type II Variation marketing authorization application for ENHERTU(R) (trastuzumab deruxtecan) in combination with pertuzumab for the first-line ...
Pharmabiz

EMA validates Type II Variation marketing application for Enhertu as post-neoadjuvant treatment for patients with HER2 positive earlybreast cancer

EMA validates Type II Variation marketing application for Enhertu as post-neoadjuvant treatment for patients with HER2 positive earlybreast cancer: Tokyo Saturday, February 21, 20 ...
Business Wire

Trastuzumab Deruxtecan Type II Variation Application Validated by EMA for Patients with HER2 Positive Metastatic Breast Cancer Treated with a Prior Anti-HER2-Based Regimen

TOKYO, Japan & MUNICH, Germany--(BUSINESS WIRE)--Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) today announced that the European Medicines Agency (EMA) has validated the Type II ...
Seeking Alpha

ENHERTU® Plus Pertuzumab Type II Variation Application Validated in the EU as First-Line Treatment of Patients with HER2 Positive Metastatic Breast Cancer

Based on DESTINY-Breast09 phase 3 trial results that showed Daiichi Sankyo and AstraZeneca’s ENHERTU in combination with pertuzumab significantly improved progression-free survival versus current ...
Seeking Alpha

DATROWAY® Type II Variation Application Validated in the EU as First-Line Treatment for Patients with Metastatic Triple Negative Breast Cancer Who are Not Candidates for ...

Based on TROPION-Breast02 phase 3 trial results where Daiichi Sankyo and AstraZeneca’s DATROWAY is the first and only medicine to significantly improve overall survival versus chemotherapy in this ...