April 19, 2021
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FDA grants priority review to Padcev for advanced urothelial cancer

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The FDA granted priority review to two supplemental biologics license applications for enfortumab vedotin-ejfv in the treatment of locally advanced or metastatic urothelial cancer.

The first application seeks to convert the accelerated approval of enfortumab vedotin-ejfv (Padcev; Astellas, Seagen) to regular approval, based on results of the phase 3 EV-301 trial. As Healio previously reported, results of that trial showed enfortumab vedotin-ejfv conferred significantly longer median OS (12.88 months vs. 8.97 months; HR = 0.7; 95% CI, 0.56-0.89) and PFS (5.55 months vs. 3.71 months; HR = 0.62; 95% CI, 0.51-0.75) compared with investigator-chosen chemotherapy among 608 patients with locally advanced or metastatic urothelial carcinoma who had previously received platinum-containing chemotherapy and had progressed during or after treatment with a PD-1 or PD-L1 inhibitor.

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The second application seeks to expand approval of enfortumab vedotin-ejfv to include patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin and who previously received a PD-1 or PD-L1 inhibitor. That application is based on data from the EV-201 trial, which showed a confirmed overall response rate of 52% (95% CI, 40.8-62.4) in a cisplatin-ineligible population.

The applications will be revied under Project Orbis, an initiative of the FDA Oncology Center of Excellence, with a target action date of Aug. 17.