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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) ...
Yahoo Finance

ENHERTU® Type II Variation Application Validated in the EU for Previously Treated Patients with HER2 Positive Metastatic Solid Tumors

Submission based on three phase 2 trials where Daiichi Sankyo and AstraZeneca’s ENHERTU showed clinically meaningful responses across a broad range of tumors If approved, ENHERTU would become the ...
Pharmabiz

Pfizer, Astellas announce EMA validates type II variation application for Padcev with Keytruda for first-line treatment of advanced bladder cancer

Pfizer Inc. and Astellas Pharma Inc. announced that the European Medicines Agency (EMA) validated for review a type II variation application for Padcev (enfortumab vedotin) with Keytruda ...