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Blinatumomab, sold under the brand name Blincyto, is a biopharmaceutical medication used for the treatment of Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia. It belongs to a class of constructed monoclonal antibodies, bi-specific T-cell engagers (BiTEs), that exert action selectively and direct the human immune system to act against tumor cells. Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that specifically targets the CD19 antigen present on B cells. Blinatumomab is given via intravenous infusion.
Read the full article on WikipediaAcute lymphoblastic leukaemia Clinical criteria: Treatment Phase: Consolidation treatment of relapsed or refractory B-precursor cell ALL Patient must have previously received PBS-subsidised induction treatment with this drug for relapsed or refractory B-precursor cell ALL, AND Patient must have achieved a complete remission; OR Patient must have achieved a complete remission with partial haematological recovery, AND The treatment must not be more than 3 treatment cycles under this restriction in a lifetime, AND Patient must not receive PBS-subsidised treatment with this drug if progressive disease develops while on this drug.
Precursor B-cell acute lymphoblastic leukaemia (Pre-B-cell ALL) Clinical criteria: Treatment Phase: Initial treatment of newly-diagnosed Pre-B-cell ALL in the consolidation phase Treatment criteria: Must be treated by a physician experienced in the treatment of haematological malignancies. Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, AND The condition must not be present in the central nervous system or testis, AND Patient must have achieved complete remission following intensive combination chemotherapy for acute lymphoblastic leukaemia (ALL); OR Patient must have Philadelphia chromosome positive ALL, and both (i) have achieved complete remission following combination therapy with a tyrosine kinase inhibitor and corticosteroids (ii) be unable to tolerate chemotherapy, AND The treatment must not be more than 2 treatment cycles under this restriction in a lifetime. According to the TGA-approved Product Information, hospitalisation is recommended at minimum for the first 3 days of the first cycle and the first 2 days of the second cycle. For all subsequent cycle starts and re-initiation (e.g. if treatment is interrupted for four or more hours), supervision by a health care professional or hospitalisation is recommended. An amount of 784 mcg will be sufficient for a continuous infusion of blinatumomab over 28 days in each cycle. Blinatumomab is not PBS-subsidised if it is administered to an in-patient in a public hospital setting. Patients who fail to demonstrate a response to PBS-subsidised treatment with this agent at the time where an assessment is required must cease PBS-subsidised therapy with this agent. The authority application must be made in writing and must include: (1) details of the proposed prescription; and (2) a completed Acute Lymphoblastic Leukaemia in complete haematological remission PBS Authority Application - Supporting Information Form; and (3) the percentage blasts in bone marrow count measured that is no more than 4 weeks old at the time of application; and (4) the date of most recent chemotherapy, and if this was the initial chemotherapy regimen or salvage therapy; or (5) the date of the course of combination therapy with a tyrosine kinase inhibitor and corticosteroid for Philadelphia chromosome positive patients.
“Blinatumomab is a bispecific T-cell engager (BiTE). It enables a patient's T cells to recognize malignant B cells. A molecule of blinatumomab combines two binding sites: a CD3 site for T cells and a CD19 site for the target B cells. CD3 is part of the T cell receptor. The drug works by linking these two cell types and activating the T cell to exert cytotoxic activity on the target cell. CD3 and CD19 are expressed in both pediatric and adult patients, making blinatumomab a potential therapeutic option for both pediatric and adult populations.”
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