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# Final Approval Granted for Astellas’ Padcev
- URL: https://www.fdaweb.com/final-approval-granted-for-astellas-padcev/
- Published: 2021-07-09T12:00:00.000Z
- Updated: 2026-09-14T17:05:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149680

FDA has granted full approval to Astellas Pharma for Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate for certain adult patients with locally advanced or metastatic urothelial cancer. The therapy was previously granted accelerated approval 12/2019.

Approval was based on data from a confirmatory trial in 608 patients with locally advanced or metastatic urothelial cancer who received a prior PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. Patients were randomized to receive either Padcev or investigator’s choice of single-agent chemotherapy (docetaxel, paclitaxel, or vinflunine). Median overall survival was 12.9 months for Padcev-treated patients versus 9.0 months for those receiving chemotherapy.

FDA says the therapy’s labeling was modified to add a Boxed Warning for serious skin reactions, including Stevens-Johnson syndrome and Toxic Epidermal Necrolysis, and a Warning for pneumonitis.