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.
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