Overview
Enfortumab vedotin is an antibody-drug conjugate used in the treatment of patients with advanced, treatment-resistant urothelial cancers. It is comprised of a fully human monoclonal antibody targeted against Nectin-4 and a microtubule-disrupting chemotherapeutic agent, monomethyl auristatin E (MMAE), joined by a protease-cleavable link. It is similar to brentuximab vedotin, another antibody conjugated with MMAE that targets CD-30 instead of Nectin-4. The clinical development of enfortumab vedotin was the result of a collaboration between Astellas Pharma and Seattle Genetics and it was first approved for use in the United States in December 2019 under the brand name Padcev. Enfortumab vedotin was later approved by the European Commission on April 13, 2022.
Background
Enfortumab vedotin is an antibody-drug conjugate used in the treatment of patients with advanced, treatment-resistant urothelial cancers. It is comprised of a fully human monoclonal antibody targeted against Nectin-4 and a microtubule-disrupting chemotherapeutic agent, monomethyl auristatin E (MMAE), joined by a protease-cleavable link. It is similar to brentuximab vedotin, another antibody conjugated with MMAE that targets CD-30 instead of Nectin-4. The clinical development of enfortumab vedotin was the result of a collaboration between Astellas Pharma and Seattle Genetics and it was first approved for use in the United States in December 2019 under the brand name Padcev. Enfortumab vedotin was later approved by the European Commission on April 13, 2022.
Indication
Enfortumab vedotin is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor, and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. Enfortumab vedotin can also be indicated in combination with pembrolizumab in adult patients with locally advanced or metastatic urothelial cancer who are not eligible for cisplatin-containing chemotherapy under accelerated approval from the FDA.
Associated Conditions
- Locally Advanced Urothelial Cancer
- Locally Advanced or Metastatic Urothelial Carcinoma (UC)
- Metastatic Urothelial Cancer
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/05/30 | Phase 2 | Recruiting | |||
2011/08/04 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| SEAGEN INC. | 51144-030 | INTRAVENOUS | 30 mg in 3 mL | 5/31/2022 | |
| SEAGEN INC. | 51144-020 | INTRAVENOUS | 20 mg in 2 mL | 5/31/2022 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 4/13/2022 | ||
Authorised | 4/13/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| PADCEV® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 30MG/VIAL | SIN16503P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 30.0 mg/vial | 5/30/2022 | |
| PADCEV® POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION 20MG/VIAL | SIN16502P | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | 20.0 mg/vial | 5/30/2022 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| PADCEV enfortumab vedotin 20 mg powder for injection vial | 355870 | Medicine | A | 7/7/2022 | |
| PADCEV enfortumab vedotin 30 mg powder for injection vial | 367410 | Medicine | A | 7/7/2022 |