- The FDA has approved enfortumab vedotin-ejfv (Nectin-4-directed antibody and microtubule inhibitor conjugate) for adult patients with locally advanced/metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.
- Further trial is required to confirm the clinical benefits.
Why this matters
- Patients who fail on initial treatment have limited options.
- "Antibody-drug conjugates are strategic tools in the targeted treatment of cancer," Richard Pazdur, director of the FDA’s Oncology Center of Excellence, said in a statement. "These conjugates combine the ability of monoclonal antibodies to target specific receptors on cancer cells and then deliver a drug to the cancer cell."
- Approval was based on a study of 125 patients with locally advanced/metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy.
- The overall response rate was 44% (complete response, 12%; partial response, 32%).
- The median duration of response was 7.6 months.
- Most common adverse events were fatigue, peripheral neuropathy, decreased appetite, rash, alopecia, nausea, altered taste, diarrhea, dry eye, pruritus, and dry skin.
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