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Merck Gets CHMP Backing for Keytruda-Padcev Combo in Bladder Cancer
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Key Takeaways
MRK's Keytruda plus Padcev gets CHMP backing as perioperative treatment for eligible MIBC patients.
The regimen is recommended before surgery and continued after radical cystectomy in eligible MIBC patients.
The European Commission will review the CHMP opinion, with a final decision expected in Q4 2026.
Merck (MRK - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) has issued a positive opinion recommending approval of a combination of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), in combination with Pfizer's (PFE - Free Report) antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin-ejfv), for expanded use in a bladder cancer indication.
The CHMP has now recommended the use of Keytruda and its subcutaneous (SC) formulation, Keytruda Qlex, each 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).
The CHMP opinion for the Keytruda plus Padcev regimen was based on data from the phase III KEYNOTE-B15 study, which was conducted in collaboration with Pfizer and Astellas.
The recommendation will now be reviewed by the European Commission (EC). A final decision from the regulatory body is expected in the fourth quarter of 2026.
If approved, the Keytruda+Padcev regimen will become the first and only PD-1 inhibitor plus ADC combination to be approved for patients with MIBC, regardless of cisplatin eligibility in Europe. The regimen is also likely to provide a new perioperative treatment option for eligible patients with this disease upon potential approval.
The Keytruda+Padcev regimen was approved by the FDA for the same indication in July 2026, based on data from the KEYNOTE-B15 study.
MRK’s Price Performance
Year to date, shares of Merck have rallied 42.4% compared with the industry’s increase of 14.3%.
Image Source: Zacks Investment Research
MRK’s Keytruda & Padcev Combo in Cisplatin-Ineligible MIBC
In June 2026, the European Commission approved Keytruda and Keytruda Qlex, each in combination with Padcev, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment in adult patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy.
This approval was based on data from the phase III KEYNOTE-905 study.
The FDA approved the Keytruda plus Padcev regimen as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment in adult patients with MIBC who are ineligible for cisplatin-based chemotherapy last November.
Merck’s biggest revenue driver, Keytruda, is approved for different types of cancer indications. The drug generated $16.40 billion in sales in the first half of 2026, up 4.2% year over year.
Pfizer’s Padcev, added from the December 2023 Seagen acquisition, generated sales worth $1.26 billion in the first half of 2026, up 30% on a year-over-year basis.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 86.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.
View the Zacks #1 Rank List
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Merck Gets CHMP Backing for Keytruda-Padcev Combo in Bladder Cancer
Key Takeaways
Merck (MRK - Free Report) announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (“CHMP”) has issued a positive opinion recommending approval of a combination of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), in combination with Pfizer's (PFE - Free Report) antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin-ejfv), for expanded use in a bladder cancer indication.
The CHMP has now recommended the use of Keytruda and its subcutaneous (SC) formulation, Keytruda Qlex, each 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).
The CHMP opinion for the Keytruda plus Padcev regimen was based on data from the phase III KEYNOTE-B15 study, which was conducted in collaboration with Pfizer and Astellas.
The recommendation will now be reviewed by the European Commission (EC). A final decision from the regulatory body is expected in the fourth quarter of 2026.
If approved, the Keytruda+Padcev regimen will become the first and only PD-1 inhibitor plus ADC combination to be approved for patients with MIBC, regardless of cisplatin eligibility in Europe. The regimen is also likely to provide a new perioperative treatment option for eligible patients with this disease upon potential approval.
The Keytruda+Padcev regimen was approved by the FDA for the same indication in July 2026, based on data from the KEYNOTE-B15 study.
MRK’s Price Performance
Year to date, shares of Merck have rallied 42.4% compared with the industry’s increase of 14.3%.
Image Source: Zacks Investment Research
MRK’s Keytruda & Padcev Combo in Cisplatin-Ineligible MIBC
In June 2026, the European Commission approved Keytruda and Keytruda Qlex, each in combination with Padcev, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment in adult patients with resectable MIBC who are ineligible for cisplatin-based chemotherapy.
This approval was based on data from the phase III KEYNOTE-905 study.
The FDA approved the Keytruda plus Padcev regimen as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment in adult patients with MIBC who are ineligible for cisplatin-based chemotherapy last November.
Merck’s biggest revenue driver, Keytruda, is approved for different types of cancer indications. The drug generated $16.40 billion in sales in the first half of 2026, up 4.2% year over year.
Pfizer’s Padcev, added from the December 2023 Seagen acquisition, generated sales worth $1.26 billion in the first half of 2026, up 30% 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 Repligen (RGEN - Free Report) and Precigen (PGEN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61 during the same time. RGEN’s shares have risen 8% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have moved from a loss of 2 cents per share to earnings of 25 cents. Earnings estimates for 2027 have increased from 25 cents to 86 cents during the same time. PGEN’s shares have rallied 86.2% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 108.96%.