Therapy Areas: Cardiovascular
Amgen Receives FDA Approval of Blincyto for Treatment of MRD-Positive B-Cell Precursor ALL in Adults and Children
3 April 2018 - - The US Food and Drug Administration has approved Thousand Oaks, California-based human therapeutics developer Amgen's (NASDAQ: AMGN) supplemental biologics license application for Blincyto (blinatumomab) for the treatment of adults and children with B-cell precursor acute lymphoblastic leukemia in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%, the company said.
This indication is approved under accelerated approval based on MRD response rate and hematological relapse-free survival (RFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.
The accelerated approval is based on results from the Phase 2 single-arm BLAST study, which found that Blincyto converted most patients to an MRD-negative state after a single cycle of therapy.
Blincyto met the primary endpoint, inducing a complete MRD response, which is no detectable MRD, in 81% of patients. Median hematological RFS was 22.3 months.
Safety results among MRD-positive patients were consistent with the known safety profile of Blincyto in relapsed or refractory B-cell precursor ALL. The most common adverse reactions (greater than 20%) were pyrexia, infusion related reactions, headache, infections (pathogen unspecified), tremor and chills.
Blincyto is a bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy that binds to CD19 expressed on the surface of cells of B-lineage origin and CD3 expressed on the surface of T cells. BiTE antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body's immune system to detect and target malignant cells.
BiTE antibody constructs help place T cells within reach of the targeted cell, with the intent of causing T cells to inject toxins and trigger the cancer cell aptosis. BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.
Amgen discovers, develops, manufactures, and delivers human therapeutics worldwide. It offers products for the treatment of illness in the areas of oncology/hematology, cardiovascular, inflammation, bone health, nephrology, and neuroscience.


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