Keytruda and Padcev Combo Secures EU Approval for Bladder Cancer Treatment

2 min read | September 04, 2024 12:19 PM PDT | By Team Kalkine Media

Google News:

Keytruda and Padcev Combo Secures EU Approval for Bladder Cancer Treatment — Image source: Shutterstock

Recent News

Oracle's AI Push Gains Ground Across Critical Services

Why is Marathon Petroleum (NYSE:MPC) moving with S&P 500 Energy?

Why AbbVie (NYSE:ABBV) Gains in S&P 500 Index Biopharma Push?

Why FactSet Research Systems Anchors Index Stability Gains Now?

Make Kalkine Media
My Trusted Source

Headlines

The European Commission has approved the Keytruda and Padcev combination for treating advanced urothelial carcinoma.
The approval follows positive data from the phase III KEYNOTE-A39 study and earlier recommendations from European medical authorities.
Keytruda and Padcev are now established as a new standard for first-line treatment in metastatic urothelial carcinoma.

Merck (NYSE:MRK) has received European Commission approval for the Keytruda and Padcev combination regimen, extending its use to the treatment of advanced urothelial carcinoma, a type of bladder cancer. This approval allows the combination of Keytruda, a renowned PD-L1 inhibitor, with Padcev, an antibody-drug conjugate from Astellas and Pfizer, for first-line treatment in adult patients with unresectable or metastatic urothelial carcinoma.

The decision was anticipated following a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency in July. This opinion was based on encouraging overall survival and progression-free survival results from the phase III KEYNOTE-A39 study, also known as the EV-302 study, conducted in partnership with Pfizer (NYSE:PFE)and Astellas (OTC:ALPMF)

This approval marks the third bladder cancer indication for Keytruda in the European Union. Earlier in the year, the European Society for Medical Oncology and the European Association of Urology endorsed the Keytruda and Padcev combination as the preferred first-line treatment for advanced urothelial cancer. With this new approval, the combination is now recognized as a standard of care in treating first-line metastatic urothelial carcinoma.

In the United States, the Keytruda and Padcev combination received approval in December 2023 for treating locally advanced or metastatic urothelial cancer. It is also approved as a standalone therapy for specific cases of advanced urothelial carcinoma and high-risk, non-muscle invasive bladder cancer unresponsive to Bacillus Calmette-Guerin.

Merck, alongside Pfizer and Astellas, is actively assessing the Keytruda and Padcev combination in various stages of urothelial cancer. Following Pfizer's acquisition of Seagen in December 2023, which included Padcev and three other antibody-drug conjugates, the company has seen strong demand for Padcev, generating $735 million in revenue in the first half of 2024.

Other notable pharmaceutical companies include Roche and Eli Lilly, with Roche seeing improved earnings estimates for 2024 and 2025, reflecting a positive trend in its financial performance.

Disclaimer

The content, including but not limited to any articles, news, quotes, information, data, text, reports, ratings, opinions, images, photos, graphics, graphs, charts, animations and video (Content) is a service of Kalkine Media LLC (Kalkine Media, we or us) and is available for personal and non-commercial use only. The principal purpose of the Content is to educate and inform. The Content does not contain or imply any recommendation or opinion intended to influence your financial decisions and must not be relied upon by you as such. Some of the Content on this website may be sponsored/non-sponsored, as applicable, but is NOT a solicitation or recommendation to buy, sell or hold the stocks of the company(s) or engage in any investment activity under discussion. Kalkine Media is neither licensed nor qualified to provide investment advice through this platform. Users should make their own enquiries about any investments and Kalkine Media strongly suggests the users to seek advice from a financial adviser, stockbroker or other professional (including taxation and legal advice), as necessary. Kalkine Media hereby disclaims any and all the liabilities to any user for any direct, indirect, implied, punitive, special, incidental or other consequential damages arising from any use of the Content on this website, which is provided without warranties. The views expressed in the Content by the guests, if any, are their own and do not necessarily represent the views or opinions of Kalkine Media. Some of the images/music that may be used on this website are copyright to their respective owner(s). Kalkine Media does not claim ownership of any of the pictures/music displayed/used on this website unless stated otherwise. The images/music that may be used on this website are taken from various sources on the internet, including paid subscriptions or are believed to be in public domain. We have used reasonable efforts to accredit the source (public domain/CC0 status) to where it was found and indicated it, as necessary.