What Is Enfortumab Vedotin (Padcev)? Its FDA Approval History

• FDA-approved: Yes (first approval: December 18, 2019)
• Active ingredient: Enfortumab vedotin
• Brand name: Padcev
• Route of administration: Intravenous (IV)
• Class: Antibody–drug conjugate
• Category: Biological response modifier, chemotherapy medicine
• Manufacturer: Astellas
• Distribution in Türkiye: Astellas
• Approved cancer indication: Metastatic urothelial cancer (bladder and urinary tract)

1. Approximately 4 MMAE molecules (the chemotherapy component) are attached to each antibody.
2. After binding to Nectin-4, enfortumab vedotin is rapidly internalized into lysosomes, releasing MMAE into the cell. MMAE binds microtubules, inhibiting mitosis and cell division and ultimately causing cell death.

• April 3, 2023: The FDA approves Merck's Keytruda (pembrolizumab) with Padcev (enfortumab vedotin-ejfv) as first-line treatment for certain cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer.
• July 9, 2021: The US FDA grants regular approval to Padcev (enfortumab vedotin-ejfv) and expands its indication for locally advanced or metastatic urothelial cancer.
• December 18, 2019: The FDA grants accelerated approval to Padcev (enfortumab vedotin-ejfv) for locally advanced or metastatic urothelial cancer previously treated with a PD-1/L1 inhibitor and a platinum-containing medicine.

Padcev, containing enfortumab vedotin, was authorized on 12.12.2023 by Türkiye's Ministry of Health. However, it has not yet been included in reimbursement coverage by SGK (the Social Security Institution).

The authorized therapeutic indication is:

"PADCEV is indicated for adults with unresectable locally advanced/metastatic urothelial carcinoma, ECOG performance status 0-1, previous platinum-based chemotherapy (if used neoadjuvantly/adjuvantly, progression must occur within 12 months of the last dose), and progression during/after PD1/PDL1 inhibitor treatment."

Enfortumab vedotin is currently available in pharmacies in Türkiye, but is not reimbursed by SGK. In some cases, a court order can require SGK to cover it.

PADCEV Price (July 2026):

• Price in Türkiye for a 20 mg vial: 27.667.82 TL
• Price in Türkiye for a 30 mg vial:  41,377.72 TL. 
• For an average 70 kg patient, a 28-day cycle costs approximately 364,030.24 TL. 
• This information is general and does not replace a doctor or pharmacist. Consult your pharmacist about prices.

Enfortumab vedotin is catabolized into small peptides, amino acids, unconjugated MMAE and related unconjugated MMAE catabolites. MMAE is a substrate of hepatic microsomal CYP3A4 enzymes. The median terminal half-life of antibody-conjugated MMAE is about 12 days, while unconjugated MMAE has a terminal half-life of about 4 days after the first antibody–drug conjugate dose.

Padcev is mainly metabolized in the liver and largely excreted through bile. Dose adjustment is therefore not assumed necessary in renal impairment.

The recommended dose is administered intravenously on days 1, 8 and 15 of a 28-day schedule at 1.25 mg/kg(up to a maximum of 125 mg).

For example, a 70-kilogram patient receives 84 mg per administration. Vials containing 30 mg and 20 mg are available.

• The infusion site should be monitored for extravasation . If it occurs, stop the infusion and monitor the patient for infusion reactions.
• Monitor serum glucose closely, particularly in patients with preexisting diabetes. Stop treatment when blood glucose is >250 mg/dL.
• Monitor for eye disorders, which occur after a median of 2 months. Consider artificial tears to prevent dry eyes.
• No dose reduction is needed for mild hepatic dysfunction. Safety information is limited in moderate or severe hepatic dysfunction, and use should be avoided.
• No dose reduction is needed for mild, moderate or severe renal dysfunction. It has not been studied in end-stage renal disease and/or patients receiving hemodialysis.
• It may harm the fetus during pregnancy. Women of reproductive potential should use effective contraception during treatment and for at least 2 months after the last dose; men should do so during treatment and for at least 4 months afterward. Breastfeeding should be avoided.

1. Fatigue and anorexia
2. Nausea/vomiting, loss of taste
3. Peripheral neuropathy
4. Hyperglycemia
5. Skin toxicity (rash, itching, dry skin)
6. Eye toxicity (dry eyes, blurred vision, keratitis)
7. Infusion-site extravasation