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FDA Approves Padcev for Treatment of Advanced Urothelial Cancer

Padcev (enfortumab vedotin-ejfv), a Nectin-4-directed antibody and microtubule inhibitor conjugate, has received accelerated approval for the treatment of locally advanced or metastatic urothelial cancer, the U.S. Food and Drug Administration announced yesterday.

Padcev is indicated for adults whose disease has progressed while receiving standard treatment with a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-based therapy.

Approval was based on clinical data from EV-201, a single-arm phase 2 multicenter trial of 125 patients with locally advanced or metastatic urothelial cancer who had previously received treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. Researchers found an overall response rate of 44 percent. Twelve and 32 percent of patients had a complete and partial response, respectively. Median response duration was 7.6 months.

The most commonly reported side effects with Padcev included fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritis, and dry skin. Patients treated with Padcev are also at risk for hyperglycemia. Physicians should closely monitor patients' blood glucose levels when they are being treated with Padcev. They should also monitor patients for new or worsening peripheral neuropathy and eye disorders such as dry eyes and vision changes. In the case of peripheral neuropathy, Padcev should be interrupted, reduced, or discontinued as needed. The FDA also noted that patients who experience infusion-site extravasation may have delayed extravasation-site reactions with pain, blisters, and skin peeling. Clinicians should ensure a patient has adequate venous access before starting Padcev treatment.

Approval was granted to Astellas Pharma US Inc.

Dec. 19, 2019


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