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MRK's sBLAs for Keytruda Combo in Bladder Cancer Get FDA Priority Tag
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Key Takeaways
MRK's sBLAs seek expanded Keytruda/Keytruda SC use with Padcev in cisplatin-eligible MIBC patients.
FDA granted priority review to the combo regimens, with a regulatory decision due on Aug. 17, 2026.
If approved, the regimens could become first perioperative MIBC options regardless of cisplatin eligibility.
Merck (MRK - Free Report) announced that the FDA has accepted the two supplemental biologics license applications (sBLAs) seeking approval for both intravenous (“IV”) and subcutaneous (under the skin or SC) formulations of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), each in combination with Pfizer’s (PFE - Free Report) antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin-ejfv), for expanded use in bladder cancer indication.
The sBLAs are seeking approval for Keytruda and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) – the SC formulation – each in combination with Padcev for the treatment of muscle-invasive bladder cancer (“MIBC”) in patients who are eligible for cisplatin-based chemotherapy.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body 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.
The sBLAs were based on data from the phase III KEYNOTE-B15 study, which was conducted in collaboration with Pfizer and Astellas.
MRK’s Price Performance
Year to date, shares of Merck have rallied 11.3% against the industry’s decline of 2.8%.
Image Source: Zacks Investment Research
FDA Nod to Keytruda Plus Padcev in Cisplatin-Ineligible MIBC
In November 2025, the FDA 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 MIBC who are ineligible for cisplatin-based chemotherapy.
This marked the first PD-1 inhibitor plus ADC regimens to be approved by the FDA for the given patient population.
The approvals for Keytruda and Keytruda Qlex, each in combination with PFE’s Padcev, were based on data from the phase III KEYNOTE-905 study, conducted in collaboration with Pfizer and Astellas.
Keytruda plus Padcev is presently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in several countries around the world, including the United States and the European Union (EU). Keytruda as a monotherapy is also approved for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer in several countries worldwide.
Merck’s biggest revenue driver, Keytruda, is approved for different types of cancer indications. The drug generated $31.7 billion in sales in 2025, up 7% year over year.
The December 2023 acquisition of Seagen added Padcev to Pfizer’s oncology portfolio. The drug generated sales worth $1.94 billion in 2025, increasing 22% on a year-over-year basis.
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have soared 40.7% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.
Over the past 60 days, Amarin's loss per share estimates for 2026 have narrowed from $7.32 to $6.36, while the same for 2027 have narrowed from $5.97 to $4.64 during the same time. AMRN stock has risen 4.7% 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 51.29%.
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MRK's sBLAs for Keytruda Combo in Bladder Cancer Get FDA Priority Tag
Key Takeaways
Merck (MRK - Free Report) announced that the FDA has accepted the two supplemental biologics license applications (sBLAs) seeking approval for both intravenous (“IV”) and subcutaneous (under the skin or SC) formulations of its blockbuster PD-L1 inhibitor, Keytruda (pembrolizumab), each in combination with Pfizer’s (PFE - Free Report) antibody-drug conjugate ("ADC"), Padcev (enfortumab vedotin-ejfv), for expanded use in bladder cancer indication.
The sBLAs are seeking approval for Keytruda and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph) – the SC formulation – each in combination with Padcev for the treatment of muscle-invasive bladder cancer (“MIBC”) in patients who are eligible for cisplatin-based chemotherapy.
With the FDA granting a priority review to the sBLA, a decision from the regulatory body 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.
The sBLAs were based on data from the phase III KEYNOTE-B15 study, which was conducted in collaboration with Pfizer and Astellas.
MRK’s Price Performance
Year to date, shares of Merck have rallied 11.3% against the industry’s decline of 2.8%.
Image Source: Zacks Investment Research
FDA Nod to Keytruda Plus Padcev in Cisplatin-Ineligible MIBC
In November 2025, the FDA 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 MIBC who are ineligible for cisplatin-based chemotherapy.
This marked the first PD-1 inhibitor plus ADC regimens to be approved by the FDA for the given patient population.
The approvals for Keytruda and Keytruda Qlex, each in combination with PFE’s Padcev, were based on data from the phase III KEYNOTE-905 study, conducted in collaboration with Pfizer and Astellas.
Keytruda plus Padcev is presently approved for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC) in several countries around the world, including the United States and the European Union (EU). Keytruda as a monotherapy is also approved for the treatment of certain patients with la/mUC or a type of non-muscle-invasive bladder cancer in several countries worldwide.
Merck’s biggest revenue driver, Keytruda, is approved for different types of cancer indications. The drug generated $31.7 billion in sales in 2025, up 7% year over year.
The December 2023 acquisition of Seagen added Padcev to Pfizer’s oncology portfolio. The drug generated sales worth $1.94 billion in 2025, increasing 22% 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 Agenus (AGEN - Free Report) and Amarin (AMRN - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) presently. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have soared 40.7% year to date.
Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%.
Over the past 60 days, Amarin's loss per share estimates for 2026 have narrowed from $7.32 to $6.36, while the same for 2027 have narrowed from $5.97 to $4.64 during the same time. AMRN stock has risen 4.7% 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 51.29%.