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MRK Gets EU Nod for Keytruda & Padcev Combination in Bladder Cancer
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Key Takeaways
Merck secured EU approval for Keytruda plus Padcev in cisplatin-ineligible MIBC patients.
The regimen is the first PD-1 inhibitor plus ADC combination to be approved in the EU for this use.
Keytruda plus Padcev regimen is approved before & after surgery for patients ineligible for cisplatin therapy.
Merck (MRK - Free Report) announced that the European Commission has approved its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), and its subcutaneous formulation, Keytruda Qlex, each in combination with Pfizer’s (PFE - Free Report) antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin-ejfv), for treating certain patients with bladder cancer.
The regulatory body in Europe has now approved Keytruda in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment in adult patients with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
Following the latest nod, the Keytruda+Padcev regimen became the first and only PD-1 inhibitor plus ADC combination to be available in the European Union for the given indication. The FDA approved the Keytruda+Padcev regimen for a similar indication in November 2025.
Last month, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approval of the combination of Keytruda plus Padcev for the given indication.
MRK’s Price Performance
Year to date, shares of Merck have rallied 16.3% compared with the industry’s rise of 6.4%.
Image Source: Zacks Investment Research
The EU approval for Keytruda+Padcev regimen was based on data from the phase III KEYNOTE-905 study, conducted in collaboration with Pfizer and Astellas.
Data from the same showed that Keytruda plus Padcev, as perioperative treatment, led to statistically significant and clinically meaningful improvements across several endpoints, including event-free survival, overall survival and pathologic complete response versus surgery alone in the given patient population.
The latest approval of the Keytruda-Padcev regimen in Europe marks a significant advancement in the treatment of resectable MIBC, providing a new perioperative treatment option that has the potential to improve outcomes and extend survival in this underserved patient population.
The approval should further expand Keytruda’s presence in bladder cancer treatment.
MRK’s Keytruda & Padcev in Cisplatin-Eligible MIBC
Keytruda in combination with Padcev is currently under review in the United States for the treatment of MIBC in patients who are eligible for cisplatin-based chemotherapy.
A decision from the FDA is expected on Aug. 17, 2026.
If approved, these regimens would be the first and only perioperative treatments for patients with MIBC, regardless of cisplatin eligibility, potentially establishing new standards of care.
Merck’s biggest revenue driver, Keytruda, is approved for different types of cancer indications. The drug generated $8.03 billion in sales in the first quarter of 2026, up 8% year over year.
The December 2023 acquisition of Seagen added Padcev to Pfizer’s oncology portfolio. The drug generated sales worth $591 million in the first quarter of 2026, up 39% on a year-over-year basis.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 13.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 119% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.
View the Zacks #1 Rank List
Image: Bigstock
MRK Gets EU Nod for Keytruda & Padcev Combination in Bladder Cancer
Key Takeaways
Merck (MRK - Free Report) announced that the European Commission has approved its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), and its subcutaneous formulation, Keytruda Qlex, each in combination with Pfizer’s (PFE - Free Report) antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin-ejfv), for treating certain patients with bladder cancer.
The regulatory body in Europe has now approved Keytruda in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment in adult patients with resectable muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.
Following the latest nod, the Keytruda+Padcev regimen became the first and only PD-1 inhibitor plus ADC combination to be available in the European Union for the given indication. The FDA approved the Keytruda+Padcev regimen for a similar indication in November 2025.
Last month, the EMA’s Committee for Medicinal Products for Human Use (“CHMP”) recommended approval of the combination of Keytruda plus Padcev for the given indication.
MRK’s Price Performance
Year to date, shares of Merck have rallied 16.3% compared with the industry’s rise of 6.4%.
Image Source: Zacks Investment Research
The EU approval for Keytruda+Padcev regimen was based on data from the phase III KEYNOTE-905 study, conducted in collaboration with Pfizer and Astellas.
Data from the same showed that Keytruda plus Padcev, as perioperative treatment, led to statistically significant and clinically meaningful improvements across several endpoints, including event-free survival, overall survival and pathologic complete response versus surgery alone in the given patient population.
The latest approval of the Keytruda-Padcev regimen in Europe marks a significant advancement in the treatment of resectable MIBC, providing a new perioperative treatment option that has the potential to improve outcomes and extend survival in this underserved patient population.
The approval should further expand Keytruda’s presence in bladder cancer treatment.
MRK’s Keytruda & Padcev in Cisplatin-Eligible MIBC
Keytruda in combination with Padcev is currently under review in the United States for the treatment of MIBC in patients who are eligible for cisplatin-based chemotherapy.
A decision from the FDA is expected on Aug. 17, 2026.
If approved, these regimens would be the first and only perioperative treatments for patients with MIBC, regardless of cisplatin eligibility, potentially establishing new standards of care.
Merck’s biggest revenue driver, Keytruda, is approved for different types of cancer indications. The drug generated $8.03 billion in sales in the first quarter of 2026, up 8% year over year.
The December 2023 acquisition of Seagen added Padcev to Pfizer’s oncology portfolio. The drug generated sales worth $591 million in the first quarter of 2026, up 39% on a year-over-year basis.
MRK’s Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Liquidia Corporation (LQDA - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss of 88 cents per share to earnings of 6 cents. Over the same period, EPS estimates for 2027 have risen from 24 cents to 87 cents. IMCR stock has lost 13.6% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $1.50 to $2.97, while estimates for 2027 have increased from $2.91 to $4.81 during the same time. LQDA shares have surged 119% year to date.
Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%.