FDA Approves MRK's Keytruda & Keytruda SC Combo in Bladder Cancer

Merck MRK announced that the FDA has approved both the intravenous (“IV”) and the subcutaneous (under the skin or SC) formulation of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), each in combination with Pfizer’s PFE antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin-ejfv), for a bladder cancer indication.

The regulatory body has now approved Keytruda and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) – the SC formulation – 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”) who are ineligible for cisplatin-based chemotherapy.

The latest FDA approvals mark the first PD-1 inhibitor plus ADC regimens to be approved for the given patient population.

MRK’s Price Performance

Year to date, shares of Merck have lost 1.7% against the industry’s rise of 16.1%.

More on the Latest FDA Nod for MRK's Keytruda With PFE’s Padcev

The approvals for Keytruda and Keytruda Qlex each in combination with Padcev was based on data from the phase III KEYNOTE-905 trial, which was conducted in collaboration with Pfizer and Astellas.

Data from the same showed that after a median follow-up of 25.6 months, treatment with Keytruda plus Padcev, as perioperative treatment, led to a statistically significant 60% reduction in the risk of event-free survival (“EFS”) events compared with surgery alone in patients with MIBC who are not eligible for or declined cisplatin-based chemotherapy.

Treatment with Keytruda plus Padcev also led to a statistically significant 50% improvement in overall survival (“OS”) versus surgery alone.

Last month, the FDA granted priority review to MRK’s two supplemental biologics license applications (sBLA) seeking approval for Keytruda and Keytruda Qlex, each in combination with PFE’s Padcev for the treatment of patients with MIBC who are ineligible for cisplatin-based chemotherapy.

The FDA’s decision was expected on April 7, 2026.

The early approval for Keytruda and Keytruda Qlex with Padcev underscores the potential of the combination regimen to address a critical unmet medical need for MIBC patients.

Merck’s biggest revenue driver, Keytruda, is approved for different types of cancer indications. The drug generated sales of $23.30 billion in the first nine months of 2025, up 8% year over year. Keytruda has played an instrumental role in driving Merck’s steady revenue growth over the past few years.

The December 2023 acquisition of Seagen added Padcev to Pfizer’s oncology portfolio. The drug generated sales worth $1.43 billion in the first nine months of 2025, increasing 25% on a year-over-year basis.

MRK’s Zacks & Stocks to Consider

Merck currently has a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are CorMedix CRMD and Castle Biosciences CSTL, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for CorMedix’s 2025 earnings per share have increased from $1.24 to $2.87. Earnings per share estimates for 2026 have moved up from $2.09 to $2.88 during the same period. CRMD stock has surged 19.5% year to date.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with an average surprise of 27.04%.

In the past 60 days, estimates for Castle Biosciences’ 2025 loss per share have narrowed from 65 cents to 23 cents. Loss per share estimates for 2026 have narrowed from $2.10 to $1.42 during the same period. CSTL stock has rallied 42.2% year to date.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with an average surprise of 66.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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