Final Approval Granted for Astellas’ Padcev

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.