KENILWORTH (NJ) (dpa-AFX) - Drug major Merck & Co., Inc. (MRK) announced Friday that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab) plus Padcev (enfortumab vedotin-ejfv) as perioperative treatment in resectable muscle-invasive bladder cancer or MIBC.
KEYTRUDA is Merck's anti-programmed death receptor-1 or PD-1 therapy that works by increasing the ability of the body's immune system to help detect and fight tumor cells.
KEYTRUDA, a humanized monoclonal antibody, blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes that may affect both tumor cells and healthy cells.
The company noted that KEYTRUDA in combination with Padcev has been recommended as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable MIBC.
The recommendation, which also includes KEYTRUDA SC, will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway. A final decision is expected by the fourth quarter of 2026.
The recommendation is based on results from the Phase 3 KEYNOTE-B15 trial, which was conducted in collaboration with Pfizer and Astellas.
In the study, KEYTRUDA plus Padcev, as perioperative treatment, demonstrated a statistically significant improvement in event-free survival, overall survival and pathologic complete response rate.
Marjorie Green, senior vice president, oncology, global clinical development, Merck Research Laboratories, stated, 'Despite advances in the treatment of muscle-invasive bladder cancer, recurrence remains a significant concern for many patients regardless of cisplatin eligibility, and up to half may be unable to receive cisplatin-based chemotherapy. If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for people with muscle-invasive bladder cancer regardless of cisplatin eligibility, expanding on the previously approved indication.'
In June 2026, the EC approved KEYTRUDA, which also includes KEYTRUDA SC, in combination with Padcev, as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable MIBC who are ineligible for cisplatin-containing chemotherapy based on the Phase 3 KEYNOTE-905 trial.
The company added that in July 2026, the U.S. Food and Drug Administration approved KEYTRUDA in combination with Padcev as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment for the treatment of adult patients with MIBC based on the Phase 3 KEYNOTE-B15 trial.
It is the first and only PD-1 inhibitor plus antibody-drug conjugate or ADC regimen approved in the U.S. for adults with MIBC regardless of cisplatin eligibility.
In the pre-market activity on the NYSE, MRK shares were losing around 0.24 percent, trading at $146.80, after closing Thursday's regular trading 1.55 percent higher.
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