The FDA has approved multiple immunotherapy regimens for muscle-invasive bladder cancer (MIBC). Pembrolizumab plus enfortumab vedotin received approval as neoadjuvant and adjuvant treatment, showing a 47% improvement in event-free survival and 35% improvement in overall survival over chemotherapy. Separately, atezolizumab was approved as adjuvant therapy for patients with ctDNA-detected residual disease after cystectomy, cutting the risk of recurrence or death by 36%.
The FDA has delivered a wave of approvals for muscle-invasive bladder cancer (MIBC), marking a significant shift in how the disease is treated before and after surgery.
Pembrolizumab (Keytruda) — alone or paired with berahyaluronidase alfa-pmph (Keytruda Qlex) — in combination with enfortumab vedotin-ejfv (Padcev) was approved as neoadjuvant treatment followed by adjuvant therapy after cystectomy. The decision was based on the phase 3 KEYNOTE-B15/EV-304 trial of 808 patients, where the regimen dramatically outperformed standard gemcitabine and cisplatin chemotherapy.
In a separate approval, atezolizumab (Tecentriq) and its subcutaneous formulation (Tecentriq Hybreza) were greenlit as adjuvant treatment for MIBC patients who test positive for circulating tumor DNA (ctDNA) molecular residual disease after cystectomy — identified via the newly FDA-authorized Signatera CDx assay. This ctDNA-guided approach allows clinicians to target immunotherapy precisely at patients most likely to relapse, while sparing others from unnecessary treatment.
By the Numbers
Why it matters: These approvals represent a major step forward for MIBC — a cancer with historically limited options. The pembrolizumab combo offers a powerful pre- and post-surgery immunotherapy strategy, while the ctDNA-guided atezolizumab approval introduces precision medicine to bladder cancer management, helping doctors act quickly for high-risk patients and avoid over-treating those who don't need it.
