US Edition
Published • loading... • Updated
FDA Grants Priority Review to sBLA for EV Plus Pembrolizumab in Cisplatin-Ineligible MIBC
- The U.S. Food and Drug Administration accepted a supplemental Biologics License Application for PADCEV™ with KEYTRUDA® to treat muscle-invasive bladder cancer.
- The pivotal EV-303 trial showed that this combination reduced the risk of recurrence, progression, or death by 60% in patients ineligible for cisplatin-containing chemotherapy.
- If approved, PADCEV with KEYTRUDA could change treatment methods for patients with muscle-invasive bladder cancer.
- The safety results of the combination were consistent with previous reports, with no new safety signals identified.
Insights by Ground AI
63 Articles
63 Articles
The Berkshire Eagle+61 Reposted by 61 other sources
PADCEV™ (enfortumab vedotin-ejfv) Plus KEYTRUDA® (pembrolizumab) sBLA Granted FDA Priority Review for Treatment of Certain Patients with Muscle-Invasive Bladder Cancer
Results from the pivotal EV-303 trial demonstrated that, when used before and after surgery, the combination reduced the risk of recurrence, progression or death by 60% and the risk of death by 50% in cisplatin-ineligible patients with muscle-invasive bladder cancer
Coverage Details
Total News Sources63
Leaning Left4Leaning Right7Center19Last UpdatedBias Distribution63% Center
Bias Distribution
- 63% of the sources are Center
63% Center
14%
C 63%
R 23%
Factuality
To view factuality data please Upgrade to Premium
