FDA to Review Pembrolizumab for Additional Kidney, Endometrial Cancer Indications
The sBLA submissions are supported by data from the phase 3 KEYNOTE-564 trial and the phase 2 KEYNOTE-158 trial.
Bladder/Kidney/Other Urologic Cancers
Opdivo Approved as Adjuvant Treatment for High Risk Urothelial Carcinoma
The approval was based on data from the phase 3 CheckMate-274 trial which evaluated nivolumab as an adjuvant treatment in 699 adults who have undergone radical surgery for invasive urothelial carcinoma at high risk of recurrence.
FDA: No Approval for Bladder Cancer Drug Vicineum
Vicineum is an investigational locally administered recombinant fusion protein that targets EpCAM antigens on the surface of tumor cells to deliver Pseudomonas Exotoxin A.
Welireg Approved for Cancers Associated With Von Hippel-Lindau Disease
The approval was based on data from an open-label phase 2 study which evaluated the efficacy and safety of Welireg in patients with von Hippel-Lindau-associated renal cell carcinoma and other VHL-associated tumors.
Padcev Gets Full Approval, Expanded Indication for Urothelial Cancer
Full approval was granted based on overall survival data from a confirmatory trial.
Devimistat Granted Orphan Drug Status for Biliary Cancer
Devimistat targets the mitochondrial tricarboxylic acid cycle selectively in cancer cells.
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