PADCEV (enfortumab vedotin-ejfv) for injection, for intravenous use. Initial U.S. Approval: 2019

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PADCEV (enfortumab vedotin-ejfv) for injection, for intravenous use. Initial U.S. Approval: 2019

INDICATIONS AND USAGE
PADCEV is a Nectin-4-directed antibody and microtubule inhibitor conjugate 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 a platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced or metastatic setting.
This indication is approved under accelerated approval based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
DOSAGE FORMS & STRENGTHS
For Injection: 20 mg and 30 mg of enfortumab vedotin-ejfv as a lyophilized powder in a single-dose vial for reconstitution.
Manufactured By: Astellas Pharma US, Inc
Prescribing Information URL: Click Here

Access to PADCEV ™ (enfortumab vedotin-ejfv) for injection: Anticancer drugs available upon request. To get best price please share your mobile number to receive quotes from Medvitaz Pharma Solutions.

 

Results of a Phase I clinical trial were reported in 2016.

In December 2019, enfortumab vedotin-ejfv was approved in the United States for the treatment of adult patients with locally advanced or metastatic urothelial cancer who had previously received a programmed cell death receptor-1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor and a platinum-containing chemotherapy.

Enfortumab vedotin was approved based on the results of a clinical trial that enrolled 125 patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1 or PD-L1 inhibitor and platinum-based chemotherapy. The overall response rate, reflecting the percentage of patients who had a certain amount of tumor shrinkage, was 44%, with 12% having a complete response and 32% having a partial response. The median duration of response was 7.6 months.

The application for enfortumab vedotin-ejfv was granted accelerated approval, priority review designation, and breakthrough therapy designation. The U.S. Food and Drug Administration (FDA) granted the approval of Padcev to Astellas Pharma US Inc.

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