Chemical Property of blinatuMoMab
Chemical Property:
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97% *data from raw suppliers
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Indications
The CD19/CD3-bispecific antibody construct blinatumomab (INN) is the first T-cell-engaging and first CD19-specific antibody approved by the Food andDrug Administration (FDA). Blinatumomab showed as single-agent treatment high clinical activity at extremely low dose levels in patients with refractory or relapsed B-cell precursor acute lymphocytic leukemia (r/r ALL) and r/r non-Hodgkin lymphoma (NHL).
Blinatumomab received conditional approval by the FDA on December 3, 2014, for treatment of Philadelphia chromosome-negative adult patients with r/r ALL. EU approval was obtained on November 24, 2015. Its conditional approval was on the basis of results from a single-arm phase II clinical trial with 185 r/r ALL patients showing a complete response rate of 41.6% and the obligation to conduct a phase III clinical trial in adult patients with r/r ALL (called TOWER) comparing blinatumomab against best standard of care. First results from the phase III study TOWER were announced by Amgen in a press release on February 5, 2016. An interim analysis of the open-label study showed a positive impact of blinatumomab on overall survival in r/r ALL patients, leading to a premature termination of the trial for ethical reasons. Clinical trials with blinatumomab monotherapy are ongoing in pediatric patients with r/r ALL, patients with Philadelphia chromosome-positive r/r ALL, and patients with diffuse large B-cell lymphoma (DLBCL), the most frequent form of NHL. Blinatumomab showed clinical activity to different extents in all B-cell malignancies investigated to date.
