Onco-Summaries: Daily Oncology Updates at a Glance

21/11/2025

Pembrolizumab + enfortumab vedotin received the FDA approval for MIBC (Ref)

The US FDA granted approval to Merck & Co./MSD pembrolizumab (anti-PD-1; both IV and SC formulations) in combination with Pfizer and Astellas' enfortumab vedotin (Nectin-4 ADC) as a neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, for the treatment of adult patients with muscle-invasive bladder cancer (MIBC) who are ineligible for cisplatin-based chemotherapy.

• The approval is based on data from the Phase 3 KEYNOTE-905 trial

  
  

• Dr. Matthew Galsky, Lillian and Howard Stratton Professor of Medicine, Director of Genitourinary Medical Oncology, Mount Sinai Tisch Cancer Center, and KEYNOTE-905 study investigator: “Pembrolizumab plus enfortumab vedotin is poised to address a critical unmet need. Half of patients with MIBC may experience cancer recurrence even after having their bladder removed, and many of these patients are ineligible to receive cisplatin. These approvals, based on striking event-free and overall survival benefits, may represent an important practice-changing advance for these patients who’ve had no new options in decades.”