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news.Amgen has submitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) seeking approval for its investigational bispecific T cell engager (BiTE) antibody construct, blinatumomab.
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Blinatumomab, the first of the BiTE antibody constructs, is indicated to treat adults with Philadelphia-negative (Ph-) relapsed/refractory B-precursor acute lymphoblastic leukemia (ALL), a rapidly progressing cancer of the blood and bone marrow.
BiTE antibody constructs represent a new immunotherapy approach that helps the body’s immune system target cancer cells.
The drug has received both orphan drug designation and breakthrough therapy designation from the FDA for the treatment of ALL.
Amgen Research and Development executive vice-president Sean Harper said the company seeks to work with regulatory authorities to make blinatumomab available for adult patients with acute lymphoblastic leukemia, who experience high relapse rates and have limited treatment options.
"The filing for blinatumomab brings us a step closer to first realizing the potential of BiTE technology and represents our commitment to evaluating this novel approach in a broad range of difficult-to-treat cancers," Harper said.
The submission of BLA includes data from a Phase II trial of adult patients with Ph- relapsed/refractory B-precursor ALL treated with blinatumomab, which met its primary endpoint.