Drug updated on 4/18/2024
| Dosage Form | Injection (intravenous; 20 mg/vial, 30 mg/vial) |
| Drug Class | Nectin-4-directed antibodies and microtubule inhibitor conjugates |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated in combination with pembrolizumab for the treatment of adult patients with locally advanced or metastatic urothelial cancer.
- 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.
- Indicated for adult patients who are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.
Summary
- Enfortumab vedotin-ejfv (Padcev) is approved for use in adult patients with locally advanced or metastatic urothelial cancer, including those who have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy. It is also recommended for adults who are ineligible for cisplatin-containing chemotherapy and have received one or more prior lines of therapy.
- The analysis was based on three systematic reviews/meta-analyses that focused on the safety, effectiveness, and comparative efficacy of enfortumab vedotin-ejfv in treating locally advanced or metastatic urothelial carcinoma.
- In terms of effectiveness, enfortumab vedotin-ejfv showed an objective response rate ranging between 44% to 47%, with a median duration of response of approximately 7.6 months and estimated overall survival of about 11.7 months.
- Safety concerns related to unique toxicities of enfortumab vedotin-ejfv require thorough monitoring to manage such adverse effects effectively.
- Compared to immune checkpoint inhibitors combined with platinum-based chemotherapy, which showed no significant improvement in overall survival in the first-line setting, enfortumab vedotin-ejfv is particularly noteworthy in cases that are multiply relapsed or refractory, due to its distinct mechanism of action as an anti-Nectin4 antibody-drug conjugate.
- Analysis of specific subgroups, such as patients with liver metastasis, suggests enfortumab vedotin-ejfv's utility across various patient subgroups within the urothelial carcinoma population.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Padcev (enfortumab vedotin-ejfv) Prescribing Information. | 2023 | Astellas Pharma US, Inc., Northbrook, Illinois |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| ESMO clinical practice guideline interim update on first-line therapy in advanced urothelial carcinoma. | 2024 | Annals of Oncology |
| Bladder cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |
| Bladder cancer, version 3.2020, NCCN clinical practice guidelines in oncology. | 2020 | Journal of the National Comprehensive Cancer Network |
| Treating bladder cancer. | 2020 | American Cancer Society |