Enfortumab vedotin-ejfv

(Padcev®)

Enfortumab vedotin-ejfv

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Drug updated on 4/18/2024

Dosage FormInjection (intravenous; 20 mg/vial, 30 mg/vial)
Drug ClassNectin-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
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  • 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.