Epkinly (epcoritamab-bysp)

BL 761324

Epkinly (epcoritamab-bysp)

BL 761324

U.S. License Holder:

Genmab US, Inc.

Date of License:

May-19-2023

Last Update:

Apr-08-2025

approved_indications FDA-Approved Indications

EPKINLY (epcoritamab-bysp) is a bispecific CD20-directed CD3 T-cell engager indicated for the treatment of:

Diffuse Large B-cell Lymphoma and High-grade B-cell Lymphoma: Adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy;

Follicular Lymphoma: Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

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Methodology

Information contained in the Venable 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 BiologicsHQ database.

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