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1 July 20265 min read
Medicine
FDA Approves Pembrolizumab With Enfortumab Vedotin for Cisplatin-Ineligible MIBC
FDA approved pembrolizumab or its subcutaneous formulation with enfortumab vedotin as perioperative treatment for cisplatin-ineligible muscle-invasive bladder cancer.
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FDA approved pembrolizumab, including Keytruda Qlex, with enfortumab vedotin as neoadjuvant treatment followed by adjuvant treatment after cystectomy for adults with muscle-invasive bladder cancer who are ineligible for cisplatin.
The approval connects immunotherapy, antibody-drug conjugate treatment and surgery in a coordinated perioperative pathway.
For cancer centres, this type of approval changes multidisciplinary planning rather than simply adding a metastatic-line option.
Why It Matters
Perioperative oncology approvals can redesign the whole treatment sequence around surgery.
What to Watch
Watch adoption by urologic oncology teams, surgical timing and real-world toxicity management.
Primary Sources
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Topics
FDABladder CancerImmunotherapyAntibody-Drug Conjugate