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FDA grants priority review to enfortumab vedotin for certain patients with urothelial cancer
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The FDA granted priority review to enfortumab vedotin for treatment of certain patients with locally advanced or metastatic urothelial cancer.
The designation applies to patients who received a PD-1/PD-L1 inhibitor, as well as platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic settings.
Enfortumab vedotin (Seattle Genetics/Astellas) is an investigational antibody-drug conjugate that targets Nectin-4, a cell adhesion molecule expressed on several solid tumors.
“The FDA’s filing of the application for enfortumab vedotin and granting of priority review is a significant milestone toward offering a new treatment to patients with advanced urothelial cancer who have a clear unmet need,” Roger Dansey, MD, chief medical officer at Seattle Genetics, said in a press release.
The FDA based the priority review on results from Cohort 1 of the single-arm, phase 2 EV-201 trial.
The cohort included 128 patients with locally advanced or metastatic urothelial cancer previously treated with a PD-1/PD-L1 inhibitor, as well as platinum-containing chemotherapy.
Objective response rate by blinded independent central review served as the primary endpoint. Secondary endpoints included duration of response, disease control rate, PFS, OS, safety and tolerability.
Results presented at this year’s ASCO Annual Meeting showed an ORR of 44% (95% CI, 35.1-53.2), including 15 (12%) complete responses and 40 (32%) partial responses. Thirty-five patients (28%) had stable disease, and 23 patients (18%) experienced disease progression.
The FDA is expected to make a decision on the biologics license application for enfortumab vedotin by March 15, 2020.
The agency previously granted breakthrough therapy designation to enfortumab vedotin for treatment of patients with locally advanced or metastatic urothelial cancer whose disease progressed during or after checkpoint inhibitor therapy.
“If approved, enfortumab vedotin will likely play an important role in the treatment of advanced urothelial cancer, and we look forward to working with the FDA as the review process advances,” Andrew Krivoshik, MD, PhD, senior vice president and oncology therapeutic area head at Astellas, said in the release.