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 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2019) — Sources
• EMA — Approved (2022) — Sources
• NMPA — Approved (2024) — Sources

Pivotal Clinical Evidence

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

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