PADCEV enfortumab vedotin

Drug Class

Nectin-4-directed antibody-drug conjugate (ADC)

Mechanism

Enfortumab vedotin is an ADC targeting Nectin-4, which is internalized and releases monomethyl auristatin E (MMAE), disrupting microtubules and causing cell cycle arrest and apoptosis.

Approved Indication

Treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC), either in combination with pembrolizumab or as a single agent after prior platinum-containing chemotherapy and PD-1/PD-L1 inhibitor therapy.

What This Means For Patients

Padcev (enfortumab vedotin) is an antibody-drug conjugate (ADC) targeting Nectin-4, used to treat advanced urothelial (bladder) cancer. It delivers a cell-killing agent directly to cancer cells that express Nectin-4. It is approved in mainland China and also clinically available under special-import regulations in the Hainan Boao Lecheng pilot zone.

Regulatory Approvals

• FDA — approved (2019) — label
• EMA — approved (2022) — source
• NMPA — approved (2024) — source

Pivotal Clinical Evidence

• EV-302 — Powles et al., N Engl J Med 2024 (NCT04223856) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761137s000lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/padcev
• https://doi.org/10.1056/NEJMoa2312117