Merck's (MRK) pembrolizumab, alone or with berahyaluronidase alfa-pmph, each in combination with enfortumab vedotin-ejfv, won US Food and Drug Administration approval on Friday as neoadjuvant treatment before surgery followed by adjuvant treatment after cystectomy for adults with muscle-invasive bladder cancer.

The approval expands the regimen's previously authorized use from patients who were ineligible for cisplatin to all patients with muscle-invasive bladder cancer who are candidates for cystectomy.

The approval was based on a late-stage trial showing statistically significant improvements in event-free survival and overall survival compared with neoadjuvant gemcitabine and cisplatin, the FDA said.

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