EMA issues positive GU cancer opinions
medwireNews: The EMA has adopted a positive opinion for enfortumab vedotin in urothelial cancer and for pembrolizumab in the adjuvant renal cell carcinoma (RCC) setting.
Enfortumab vedotin, a nectin-4–directed antibody–drug conjugate, is indicated for people with locally advanced or metastatic urothelial cancer that has progressed after treatment with platinum-based chemotherapy and a PD-1 or PD-L1 inhibitor.
The recommendation for marketing authorization is based on the phase 3 EV-301 trial that showed a significant improvement in both overall and progression-free survival with enfortumab vedotin versus single-agent chemotherapy in this patient population.
The EMA’s Committee for Medicinal Products for Human Use has recommended extending the indication of pembrolizumab to include the adjuvant treatment of adults with RCC at high risk for recurrence after nephrectomy with or without resection of metastatic lesions.
The use of pembrolizumab monotherapy in this setting was tested in the KEYNOTE-564 study, which demonstrated a significant disease-free survival advantage with the PD-1 inhibitor relative to placebo.
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