MSD’s Keytruda and Padcev combination receives EC approval

The clearance permits the therapies to be administered before radical cystectomy as neoadjuvant therapy and continued following surgery as adjuvant treatment.

Applicable to patients irrespective of cisplatin eligibility, the authorisation covers Iceland, Liechtenstein, Norway, and all 27 EU member states.

The regulatory decision also encompasses Keytruda SC, marketed in the US as Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph).

MSD research laboratories senior vice-president and oncology, global clinical development head Dr Marjorie Green said: “Building on the previous approval of Keytruda plus Padcev in the European Union less than six months ago, we’re pleased to bring this important treatment option to a broader patient population as the first PD-1 inhibitor plus antibody-drug conjugate regimen approved for people with muscle-invasive bladder cancer regardless of cisplatin eligibility.

“This approval represents encouraging progress in bladder cancer care and underscores our commitment to addressing the needs of people who are living with this disease.”

The decision follows a positive opinion granted last month by the European Medicines Agency’s Committee for Medicinal Products for Human Use.

The assessment was based on the open-label, randomised Phase III KEYNOTE-B15 study, also designated EV-304, conducted alongside Astellas and Pfizer.

In 808 patients, perioperative treatment lowered the risk of disease recurrence, progression, or death by 47% compared to neoadjuvant cisplatin and gemcitabine chemotherapy alongside surgical resection.

MSD stated that local availability across Europe will depend on country-level reimbursement processes.

The decision follows regulatory clearance from the US Food and Drug Administration in July 2026.

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