We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Merck's Keytruda & Padcev Combo Gets EU Nod for Urothelial Carcinoma
Read MoreHide Full Article
Merck (MRK - Free Report) announced that the European Commission has granted approval to a combination regimen of its blockbuster PD-L1 inhibitor, Keytruda, for expanded use in a type of bladder cancer. The approval is for Keytruda in combination with Astellas/Pfizer’s (PFE - Free Report) antibody-drug conjugate Padcev for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma, a type of bladder cancer.
The approval was expected as, in July, the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion recommending the approval of the Keytruda+Padcev combo for this indication. The approval was based on positive overall survival and progression-free survival data from the phase III KEYNOTE-A39 study (also known as the EV-302 study). The study was conducted in collaboration with Pfizer and Astellas.
Merck’s stock has risen 6.9% so far this year compared with an increase of 28.6% for the industry.
Image Source: Zacks Investment Research
This becomes the third bladder cancer indication approval for Keytruda in the EU. Earlier this year, the European Society for Medical Oncology and the European Association of Urology issued guidelines recommending the Keytruda+Padcev combo as the preferred option for first-line treatment of advanced urothelial cancer. The approval of the Keytruda+Padcev combination offers a new standard of care treatment in first-line metastatic urothelial carcinoma.
Keytruda+Padcev was approved for treating locally advanced or metastatic urothelial cancer in the United States in December 2023. It is also approved as a monotherapy for certain patients with locally advanced or metastatic urothelial carcinoma and Bacillus Calmette-Guerin unresponsive, high-risk, non-muscle invasive bladder cancer.
Merck, in collaboration with Pfizer and Astellas, is evaluating the Keytruda+Padcev combo in various stages of urothelial cancer.
Padcev was added to Pfizer’s cancer portfolio with the December 2023 acquisition of Seagen along with three other ADCs — Adcetris, Tukysa and Tivdak. Pfizer is witnessing strong demand for Padcev. The drug generated sales of $735 million in revenues in the first half of 2024.
In the past 60 days, 2024 earnings estimates for Roche have improved from $2.45 per share to $2.68 per share. For 2025, earnings estimates have improved from $2.64 per share to $2.87 per share over the same timeframe. Roche’s shares have risen 13.6% year to date.
Estimates for Lilly’s 2024 earnings have risen from $13.61 to $16.23 per share over the past 60 days. For 2025, earnings estimates have risen from $19.27 to $23.45 per share over the same timeframe. Year to date, Lilly’s stock has risen 64.1%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
Merck's Keytruda & Padcev Combo Gets EU Nod for Urothelial Carcinoma
Merck (MRK - Free Report) announced that the European Commission has granted approval to a combination regimen of its blockbuster PD-L1 inhibitor, Keytruda, for expanded use in a type of bladder cancer. The approval is for Keytruda in combination with Astellas/Pfizer’s (PFE - Free Report) antibody-drug conjugate Padcev for the first-line treatment of adult patients with unresectable or metastatic urothelial carcinoma, a type of bladder cancer.
The approval was expected as, in July, the Committee for Medicinal Products for Human Use of the European Medicines Agency gave a positive opinion recommending the approval of the Keytruda+Padcev combo for this indication. The approval was based on positive overall survival and progression-free survival data from the phase III KEYNOTE-A39 study (also known as the EV-302 study). The study was conducted in collaboration with Pfizer and Astellas.
Merck’s stock has risen 6.9% so far this year compared with an increase of 28.6% for the industry.
Image Source: Zacks Investment Research
This becomes the third bladder cancer indication approval for Keytruda in the EU. Earlier this year, the European Society for Medical Oncology and the European Association of Urology issued guidelines recommending the Keytruda+Padcev combo as the preferred option for first-line treatment of advanced urothelial cancer. The approval of the Keytruda+Padcev combination offers a new standard of care treatment in first-line metastatic urothelial carcinoma.
Keytruda+Padcev was approved for treating locally advanced or metastatic urothelial cancer in the United States in December 2023. It is also approved as a monotherapy for certain patients with locally advanced or metastatic urothelial carcinoma and Bacillus Calmette-Guerin unresponsive, high-risk, non-muscle invasive bladder cancer.
Merck, in collaboration with Pfizer and Astellas, is evaluating the Keytruda+Padcev combo in various stages of urothelial cancer.
Padcev was added to Pfizer’s cancer portfolio with the December 2023 acquisition of Seagen along with three other ADCs — Adcetris, Tukysa and Tivdak. Pfizer is witnessing strong demand for Padcev. The drug generated sales of $735 million in revenues in the first half of 2024.
MRK’s Zacks Rank & Stocks to Consider
Merck currently has a Zacks Rank #3 (Hold).
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Some better-ranked drug/biotech companies are Roche (RHHBY - Free Report) and Eli Lilly (LLY - Free Report) . While Roche sports a Zacks Rank #1 (Strong Buy), Lilly carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, 2024 earnings estimates for Roche have improved from $2.45 per share to $2.68 per share. For 2025, earnings estimates have improved from $2.64 per share to $2.87 per share over the same timeframe. Roche’s shares have risen 13.6% year to date.
Estimates for Lilly’s 2024 earnings have risen from $13.61 to $16.23 per share over the past 60 days. For 2025, earnings estimates have risen from $19.27 to $23.45 per share over the same timeframe. Year to date, Lilly’s stock has risen 64.1%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.