Merck's Keytruda Combination Wins Expanded FDA Approval for Muscle Invasive Bladder Cancer
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. Price: $124.05, Change: $-1.02, Percent Change: -0.82%
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.
Price: $124.05, Change: $-1.02, Percent Change: -0.82%