Weekly Digest - October 2026
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Weekly Digest - October 2026
23 October 2026: European Commission expands PADCEV + Keytruda approval to resectable MIBC, regardless of cisplatin eligibility
- Astellas announced that the European Commission has expanded the approval of PADCEV plus Keytruda to adults with resectable muscle-invasive bladder cancer, regardless of cisplatin eligibility, as perioperative treatment alongside radical cystectomy
- The approval is based on the phase 3 EV-304 trial, in which the combination reduced the risk of disease progression, recurrence or death by 47% (HR=0.53) and the risk of death by 35% (HR=0.65) versus neoadjuvant gemcitabine plus cisplatin chemotherapy and surgery. The combination also improved the pathological complete response rate to 55.8% versus 32.5%
- The approval addresses a significant unmet need in MIBC, where the risk of recurrence remains high even after curative-intent surgery. By extending the combination to cisplatin-eligible patients, it provides an alternative perioperative treatment approach beyond the previously approved option for patients ineligible for cisplatin-based chemotherapy
- PADCEV is a Nectin-4-directed ADC comprising an antibody linked to the microtubule-disrupting payload monomethyl auristatin E, while Keytruda is an anti-PD-1 immune checkpoint inhibitor. The combination pairs targeted delivery of a cytotoxic payload with immune checkpoint blockade to improve antitumor activity
- Strategically, the expanded EU approval broadens perioperative PADCEV plus Keytruda to patients with resectable MIBC regardless of cisplatin eligibility, strengthening the regimen’s reach and reinforcing ADC-immunotherapy combinations in earlier-stage bladder cancer
