Nasdaq

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

NEW YORK& TOKYO---- Pfizer Inc. and Astellas Pharma Inc. today announced that on January 26 the European Medicines Agency validated for review a Type II variation application for PADCEV ® with ...
Seeking Alpha

European Medicines Agency Validates Type II Variation for Astellas' XTANDI® (enzalutamide) for Treatment of Non-Metastatic Hormone-Sensitive Prostate Cancer with High-Risk ...

Application based on results from Phase 3 EMBARK trial, which showed XTANDI plus leuprolide reduced risk of metastasis or death by 58% TOKYO, Sept. 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: ...
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 ...
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 ...
WGN-TV

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

The Type II variation application for first-line use of the combination is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The study found the combination improved ...