Padcev (enfortumab vedotin-ejfv)

BL 761137

Padcev (enfortumab vedotin-ejfv)

BL 761137

U.S. License Holder:

Astellas

Date of License:

December-18-2019

Last Update:

July-23-2021

approved_indications FDA-Approved Indications

PADCEV (enfortumab vedotin-ejfv) 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 platinum-containing chemotherapy, or

Are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

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Methodology

Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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