Enfortumab vedotin
Enfortumab vedotin is an ADC against Nectin-4 that, combined with pembrolizumab, nearly doubled survival in advanced bladder cancer.
EV-302 (2023): enfortumab vedotin plus pembrolizumab versus platinum chemotherapy in first-line advanced urothelial cancer, OS 31.5 vs 16.1 months (HR 0.47). Now the global standard. Being tested in muscle-invasive bladder cancer (EV-303/304, positive in 2025). Rash, neuropathy, and hyperglycaemia are class effects.
1.Antibody binds Nectin-4 on the tumour cell surface
- Route
- IV infusion over 30 min
- Schedule
- 1.25 mg/kg (max 125 mg) days 1, 8, 15 of 28-day cycle (monotherapy) or days 1 and 8 of 21-day cycle with pembrolizumab
- Dose modifications
- Hold for grade 3 rash or hyperglycaemia; discontinue for SJS/TEN or grade ≥3 neuropathy
- Monitoring
- Skin, glucose (HbA1c/BMI risk), neuropathy, eyes
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. HCPCS J9177.
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- Astellas Pharma Support Solutions
- Seagen Secure (Pfizer)
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Locally advanced or metastatic urothelial cancer after platinum chemotherapy and a PD-1/PD-L1 inhibitor
- Notes
- First-line combination with pembrolizumab (EV-302) appraised separately; check NICE for the current position.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA982 · SMC advice: enfortumab vedotin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
- Mar 2018DesignationUS
Breakthrough Therapy designation source
- 18 Dec 2019ApprovalUS
Accelerated approval, advanced urothelial cancer after platinum and PD-1/PD-L1 (EV-201) source
- 9 Jul 2021ApprovalUS
Full approval and cisplatin-ineligible expansion (EV-301) source
- 3 Apr 2023ApprovalUS
Accelerated approval with pembrolizumab, cisplatin-ineligible first line source
- 15 Dec 2023ApprovalUS
Full approval with pembrolizumab, all first-line advanced urothelial cancer (EV-302) source
- Q4 2025Filing / dealUS
Muscle-invasive bladder cancer (EV-303/304) submissions following positive results source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2019 | Advanced urothelial cancer after platinum and PD-1/PD-L1 (accelerated) |
| US | 2023 | First-line advanced urothelial cancer with pembrolizumab |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Rash | 68% | 15% |
| Peripheral neuropathy | 67% | 8% |
| Fatigue | 51% | 6% |
| Pruritus | 41% | 1.1% |
| Diarrhoea | 38% | 4.5% |
| Alopecia | 35% | 0.5% |
| Decreased appetite | 33% | 1.8% |
| Weight decrease | 33% | 3.6% |
| Dry eye | 24% | 0% |
| Hyperglycaemia (grade 3-4 glucose elevation) | — | 14% |
EV-302 with pembrolizumab, n=440. Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | padcev.com/support |
| United Kingdom | NICE: recommended with pembrolizumab for untreated advanced urothelial cancer (2024) | not disclosed | — |
| European Union | EMA approved 2022 (monotherapy), 2024 (with pembrolizumab) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Enfortumab vedotin" OR ABSTRACT:"Enfortumab vedotin" OR TITLE:"Padcev" OR ABSTRACT:"Padcev") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Enfortumab vedotin, not a curated reading list.