FDA Approval Summary: Enfortumab Vedotin plus Pembrolizumab for Locally Advanced or Metastatic Urothelial Carcinoma.

Autor:	Brave MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Maguire WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Weinstock C; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhang H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Gao X; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Li F; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Yu J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fu W; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Zhao H; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pierce WF; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Chang E; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Dinin J; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Fiero MH; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Rahman NA; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Tang S; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Pazdur R; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Kluetz PG; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.; Oncology Center of Excellence, U.S. Food and Drug Administration, Silver Spring, Maryland., Amiri-Kordestani L; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland., Suzman DL; Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2024 Nov 01; Vol. 30 (21), pp. 4815-4821.
DOI:	10.1158/1078-0432.CCR-24-1393
Abstrakt:	On December 15, 2023, the FDA granted traditional approval to enfortumab vedotin-ejfv plus pembrolizumab (EV + Pembro) for patients with locally advanced or metastatic urothelial carcinoma (la/mUC). Substantial evidence of effectiveness was obtained from EV-302/KEYNOTE-A39 (NCT04223856), an open-label, randomized trial evaluating EV + Pembro versus cisplatin or carboplatin plus gemcitabine (Plat + Gem) in patients with previously untreated la/mUC. A total of 886 patients were randomized (1:1) to receive EV 1.25 mg/kg intravenously on days 1 and 8 of each 21-day cycle until disease progression or unacceptable toxicity plus Pembro 200 mg intravenously on day 1 of each 21-day cycle for up to 35 cycles or Plat + Gem for up to 6 cycles. Dual primary endpoints were progression-free survival determined by blinded independent central review and overall survival. The median progression-free survival was 12.5 months [95% confidence interval (CI), 10.4-16.6] in the EV + Pembro arm and 6.3 months (95% CI, 6.2-6.5) in the Plat + Gem arm [HR, 0.450 (95% CI, 0.377-0.538); P value < 0.0001]. The median overall survival was 31.5 months (95% CI, 25.4-not estimable) in the EV + Pembro arm and 16.1 months (95% CI, 13.9-18.3) in the Plat + Gem arm [HR, 0.468 (95% CI, 0.376-0.582); P value < 0.0001]. The safety profile of EV + Pembro was similar to that observed in EV-103/KEYNOTE-869 in cisplatin-ineligible patients with la/mUC. This article summarizes the data and the FDA thought process supporting traditional approval of EV + Pembro, as well as additional exploratory analyses conducted by the FDA. (©2024 American Association for Cancer Research.)
Databáze:	MEDLINE
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