MSD’s Keytruda-Padcev combo secures EC approval for MIBC

The authorisation applies to adults with resectable MIBC who cannot be treated with cisplatin-based chemotherapy.

It makes the combination the first regimen that pairs a programmed death-1 (PD-1) inhibitor and an antibody-drug conjugate to be available to this patient group across all 27 EU countries, as well as in Iceland, Liechtenstein and Norway.

The approval is based on results from the Phase III KEYNOTE-905/EV-303 trial, conducted in partnership with Pfizer and Astellas.

The trial found that patients receiving the combination had statistically significant and clinically meaningful improvements in event-free survival (EFS), overall survival, and pathologic complete response rates compared to those who underwent surgery alone.

Data showed that the combination reduced the risk of EFS events by 60%, with median EFS not reached for the combination versus 15.7 months for surgery alone.

Additionally, the risk of death was reduced by 50% with the combination therapy. The pathologic complete response rate was 57.1% with Keytruda plus Padcev compared to 8.6% for surgery alone.

MSD Research Laboratories senior vice-president and oncology, global clinical development head Dr Marjorie Green said: “For patients with resectable muscle-invasive bladder cancer in Europe, this approval represents a meaningful advance after years of limited progress in the field.

“As the first PD-1 inhibitor plus antibody-drug conjugate regimen approved in this setting, this treatment is poised to address a crucial unmet need, reflecting our continued commitment to delivering innovative Keytruda-based therapies to patients with bladder cancer worldwide.”

The decision follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use made in May 2026.

Commercial availability in each EU country will depend on the completion of national reimbursement processes.

Both Keytruda and Padcev were previously approved for a similar indication in the US in November 2025.

The ongoing KEYNOTE-905/EV-303 trial enrolled 595 patients and is evaluating several combinations and sequences of perioperative treatments compared with surgery alone.

Earlier this month, MSD received approval from the US Food and Drug Administration (FDA) for both Keytruda and Keytruda Qlex (pembrolizumab and berahyaluronidase alfa-pmph), in combination with Welireg (belzutifan), as adjuvant treatment for adults with renal cell carcinoma with a clear cell component (ccRCC).

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