Blincyto® (blinatumomab)

BL 125557

Blincyto® (blinatumomab)

BL 125557

U.S. License Holder:

Amgen

Date of License:

December-03-2014

Last Update:

July-23-2021

approved_indications FDA-Approved Indications

BLINCYTO (blinatumomab) is a bispecific CD19-directed CD3 T-cell engager indicated for the treatment of adults and children with:

CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1 percent;

Relapsed or refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (ALL).

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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