The National Institute for Health and Care Excellence (NICE) in the UK is seeking additional data on Amgen’s Blincyto (blinatumomab) to treat adults with acute lymphoblastic leukaemia (ALL).
The committee concluded that Blincyto holds capacity to offer significant clinical benefits, while addition data on cost-effectiveness is required to evaluate its credibility for NHS funding.
NICE has also said that it requires further clarification from Amgen for the second committee meeting in April.
Produced by Amgen, Blincyto is licensed to treat B-cell precursor ALL in patients who still have detectable
Blincyto is claimed to be the first and only ispecific CD19-directed CD3 T cell engager antibody construct.
Blincyto activates endogenous T cells by linking the CD3 antigen in the T cell receptor complex with the CD19 surface antigen on benign and malignant B cells.
The treatment is said to mediate the formation of a synapse between the T cell and the tumor cell, upregulation of cell adhesion molecules, production of cytolytic proteins, release of inflammatory cytokines, and proliferation of T cells.
In January this year, the European Commission (EC) has approved an expanded indication for Blincyto monotherapy to include adult patients with Philadelphia chromosome negative (Ph-) CD19 positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
The approval was based on data from the phase 2 Blast study, which demonstrated that Blincyto induced a complete MRD response or no detectable MRD in 78% of patients within one treatment cycle.
In April 2018, the US Food and Drug Administration (FDA) Amgen’s supplemental Biologics License Application (sBLA) for Blincyto for B-cell precursor ALL in first or second complete remission in adults and children.
Acute lymphoblastic leukemia is a cancer of the lymphoid line of blood cells characterized by the development of large numbers of immature lymphocytes. The symptoms of the disease include feeling tired, pale skin color, fever, easy bleeding or bruising, enlarged lymph nodes, or bone pain.