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20-12-2019 | FDA | News


Enzalutamide, enfortumab vedotin-ejfv receive FDA nods

medwireNews: The US FDA has expanded the indication for enzalutamide to include metastatic castration-sensitive prostate cancer and granted accelerated approval for the use of enfortumab vedotin-ejfv for advanced urothelial carcinoma.

Enzalutamide has previously been approved for the treatment of metastatic and nonmetastatic castration-resistant prostate cancer and the latest indication follows progression-free survival findings from the ARCHES trial, which favored use of the antiandrogen agent over placebo in men who have undergone bilateral orchiectomy or are receiving a gonadotropin-releasing hormone analog.

The recommended enzalutamide dose is 160 mg once daily with or without food.


The Nectin-4-directed antibody–drug conjugate enfortumab vedotin-ejfv has become the first agent of its class to receive FDA approval.

The agent may be given to patients with urothelial cancer who have previously been given a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy for locally advanced or metastatic disease. The decision follows results from the EV-201 study, which showed “substantial clinical activity”.

Enfortumab vedotin-ejfv has a recommended dose of 1.25 mg/kg given as a 30-minute infusion on days 1, 8 and 15 of a 28-day cycle. Following reports of diabetic ketoacidosis, blood glucose must be closely monitored during treatment for patients at risk for diabetes or hyperglycemia.

By Lynda Williams

medwireNews is an independent medical news service provided by Springer Healthcare. © 2019 Springer Healthcare part of the Springer Nature group