We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
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.
FDA Expands MRK & PFE's Keytruda-Padcev Combo Use in Bladder Cancer
Read MoreHide Full Article
Key Takeaways
Merck secured expanded FDA approval for Keytruda plus Padcev in muscle-invasive bladder cancer.
MRK's KEYNOTE-B15 study showed a 47% reduction in event-free survival risk versus chemotherapy.
Keytruda plus Padcev is the first approved PD-1 plus ADC regimen for MIBC regardless of cisplatin eligibility.
Merck (MRK - Free Report) announced that the FDA has approved its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), and its subcutaneous (SC) formulation, Keytruda Qlex, each 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 FDA has now approved Keytruda and Keytruda Qlex, each in combination with Padcev, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment in adult patients with muscle-invasive bladder cancer (MIBC).
Following the latest nod, the Keytruda+Padcev regimen became the first and only PD-1 inhibitor plus ADC combination to be approved for patients with MIBC, regardless of cisplatin eligibility. The latest FDA approval for the Keytruda+Padcev regimen was based on data from the phase III KEYNOTE-B15 study, conducted in collaboration with Pfizer and Astellas.
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. This approval was based on data from the phase III KEYNOTE-905 study.
MRK’s Price Performance
Year to date, shares of Merck have rallied 19.1% while those of Pfizer have gained 0.4% compared with the industry’s increase of 12.1%.
Image Source: Zacks Investment Research
More on the Latest FDA Nod for MRK & PFE’s Keytruda+Padcev Combo
Data from the KEYNOTE-B15 study showed that treatment with Keytruda plus Padcev, given before and after surgery, led to a statistically significant improvement in event-free survival (EFS), reducing the risk of EFS events by 47% in patients with MIBC who are eligible for cisplatin-based chemotherapy compared to neoadjuvant chemotherapy (gemcitabine and cisplatin) and surgery.
In April 2026, the FDA accepted and granted priority review to MRK’s supplemental biologics license applications (sBLAs) seeking approval for Keytruda and Keytruda Qlex, each in combination with Padcev, for treating MIBC in patients who are eligible for cisplatin-based chemotherapy. The decision was due on Aug. 17, 2026
The latest FDA approval, which comes a month ahead of the scheduled date, marks a significant advancement in the treatment of MIBC. The Keytruda-Padcev regimen is likely to provide a new perioperative treatment option for eligible patients with this disease.
Last month, the European Commission approved the Keytruda-Padcev regimen 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.
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.
Pfizer’s Padcev, added from the December 2023 Seagen acquisition, generated sales worth $591 million in the first quarter of 2026, up 39% on a year-over-year basis.
As both companies prepare to report their second-quarter results next month, investors are expected to closely watch the sales performance of Keytruda and Padcev, especially in light of their recent approvals.
MRK & PFE Zacks Rank
Both Merck and Pfizer currently carry a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Amarin’s 2026 loss per share have narrowed from $15.20 to 65 cents. Over the same period, loss per share estimates for 2027 have narrowed from $13.00 to 51 cents. AMRN shares have increased 6.6% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.10 to $3.02, while estimates for 2027 have increased from $4.14 to $4.92 during the same time. LQDA shares have surged 126% 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
FDA Expands MRK & PFE's Keytruda-Padcev Combo Use in Bladder Cancer
Key Takeaways
Merck (MRK - Free Report) announced that the FDA has approved its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), and its subcutaneous (SC) formulation, Keytruda Qlex, each 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 FDA has now approved Keytruda and Keytruda Qlex, each in combination with Padcev, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment in adult patients with muscle-invasive bladder cancer (MIBC).
Following the latest nod, the Keytruda+Padcev regimen became the first and only PD-1 inhibitor plus ADC combination to be approved for patients with MIBC, regardless of cisplatin eligibility. The latest FDA approval for the Keytruda+Padcev regimen was based on data from the phase III KEYNOTE-B15 study, conducted in collaboration with Pfizer and Astellas.
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. This approval was based on data from the phase III KEYNOTE-905 study.
MRK’s Price Performance
Year to date, shares of Merck have rallied 19.1% while those of Pfizer have gained 0.4% compared with the industry’s increase of 12.1%.
Image Source: Zacks Investment Research
More on the Latest FDA Nod for MRK & PFE’s Keytruda+Padcev Combo
Data from the KEYNOTE-B15 study showed that treatment with Keytruda plus Padcev, given before and after surgery, led to a statistically significant improvement in event-free survival (EFS), reducing the risk of EFS events by 47% in patients with MIBC who are eligible for cisplatin-based chemotherapy compared to neoadjuvant chemotherapy (gemcitabine and cisplatin) and surgery.
In April 2026, the FDA accepted and granted priority review to MRK’s supplemental biologics license applications (sBLAs) seeking approval for Keytruda and Keytruda Qlex, each in combination with Padcev, for treating MIBC in patients who are eligible for cisplatin-based chemotherapy. The decision was due on Aug. 17, 2026
The latest FDA approval, which comes a month ahead of the scheduled date, marks a significant advancement in the treatment of MIBC. The Keytruda-Padcev regimen is likely to provide a new perioperative treatment option for eligible patients with this disease.
Last month, the European Commission approved the Keytruda-Padcev regimen 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.
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.
Pfizer’s Padcev, added from the December 2023 Seagen acquisition, generated sales worth $591 million in the first quarter of 2026, up 39% on a year-over-year basis.
As both companies prepare to report their second-quarter results next month, investors are expected to closely watch the sales performance of Keytruda and Padcev, especially in light of their recent approvals.
MRK & PFE Zacks Rank
Both Merck and Pfizer currently carry a Zacks Rank #3 (Hold).
Stocks to Consider
Some better-ranked stocks in the biotech sector are Amarin (AMRN - 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 Amarin’s 2026 loss per share have narrowed from $15.20 to 65 cents. Over the same period, loss per share estimates for 2027 have narrowed from $13.00 to 51 cents. AMRN shares have increased 6.6% year to date.
Amarin’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%.
Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.10 to $3.02, while estimates for 2027 have increased from $4.14 to $4.92 during the same time. LQDA shares have surged 126% 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%.