PADCEV is a prescription medicine. PADCEV is used to treat bladder cancer and cancers of the urinary tract (renal pelvis, ureter or urethra) that has spread or cannot be removed by surgery.
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.
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
South Delhi Pharma can facilitate the supply of “PADCEV ™ (enfortumab vedotin-ejfv) for injection” to all locations in India and other part of countries after fulfilling the legal requirement (if applicable). All Anticancer drugs available upon request. To get best price please share your mobile number to receive quotes from South Delhi Pharma.
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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.