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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.
Ball-and-stick model from PubChem 2D record (no 3D conformer available). PubChem record
Fully human anti-Nectin-4 IgG1; MMAE released by cathepsin B; bystander killing. Connects to Nectin-4.
1.Antibody binds Nectin-4 on the tumour cell surface
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
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.
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.
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.
Sources: NICE TA982 · SMC advice: enfortumab vedotin. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2023-03-13 | Seagen to Pfizer (incl. Seagen) Padcev, Tivdak, Adcetris, Tukysa and the vedotin ADC platform | Acquisition | not disclosed | $43bn | source |
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Breakthrough Therapy designation source
Adults with locally advanced or metastatic urothelial cancer who received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant, locally advanced, or metastatic setting
Accelerated approval, advanced urothelial cancer after platinum and PD-1/PD-L1 (EV-201) source
Adults with locally advanced or metastatic urothelial cancer who received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant, locally advanced, or metastatic setting
Full approval and cisplatin-ineligible expansion (EV-301) source
In combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy
Accelerated approval with pembrolizumab, cisplatin-ineligible first line source
In combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy
Full approval with pembrolizumab, all first-line advanced urothelial cancer (EV-302) source
Muscle-invasive bladder cancer (EV-303/304) submissions following positive results source
Muscle-invasive bladder cancer with pembrolizumab, with or without berahyaluronidase alfa source
| 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 |
| EU | 2022 | mUC after platinum + PD-1; 1L with pembrolizumab 2024 |
| 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.
Read for the class this product belongs to (antibody-drug conjugates with an mmae payload) unless the answer names the product. Population figures from the cohorts named, not a prediction for one person. Blank where no source gives a recovery figure.
| 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.
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Query 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.
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