Pfizer And Astellas Pharma Announce European Medicines Agency Validates Type II Variation Application For PADCEV With KEYTRUDA For Treatment Of Advanced Bladder Cancer
Portfolio Pulse from Benzinga Newsdesk
Pfizer and Astellas Pharma have announced that the European Medicines Agency (EMA) has validated their Type II Variation Application for PADCEV combined with KEYTRUDA for the treatment of advanced bladder cancer. The pivotal trial demonstrated that this combination significantly extended overall and progression-free survival. If approved, it would be the first such combination in the EU to offer an alternative to the current standard platinum-containing chemotherapy for first-line locally advanced or metastatic urothelial cancer.
January 26, 2024 | 5:02 pm
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POSITIVE IMPACT
Merck's KEYTRUDA, in combination with Astellas Pharma's PADCEV, has received EMA validation for the treatment application of advanced bladder cancer, signaling potential growth in the EU market.
The EMA's validation of the application for the combination of KEYTRUDA and PADCEV is a positive signal for Merck, as it could lead to increased usage and sales of KEYTRUDA in the EU. This news is likely to be taken positively by the market, given the potential for revenue growth in Merck's oncology portfolio.
CONFIDENCE 80
IMPORTANCE 60
RELEVANCE 70
POSITIVE IMPACT
Pfizer's application for PADCEV with KEYTRUDA has been validated by the EMA, indicating progress towards expanding treatment options for advanced bladder cancer in the EU.
The validation of the application by the EMA is a positive development for Pfizer, potentially leading to an expanded market for PADCEV in combination with KEYTRUDA in the EU. This could improve the company's revenue prospects in the oncology segment and is likely to be viewed favorably by investors.
CONFIDENCE 85
IMPORTANCE 70
RELEVANCE 80