Merck MRK 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 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%.
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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 and Liquidia Corporation LQDA, 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%.
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