Blincyto® (Blinatumomab / MT103)
Blincyto® (blinatumomab) is a monoclonal antibody indicated as a treatment for relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL) in adults and children.
The drug was originally developed by Micromet in association with MedImmune and later moved to Amgen following its acquisition of Micromet in January 2012.
Blinatumomab was granted orphan drug designation in February 2006 by the FDA for some types of indolent B cell lymphoma, acute lymphoblastic leukaemia and chronic lymphocytic leukaemia.
The European Medicines Agency (EMEA) granted orphan drug designation to blinatumomab for the treatment of chronic lymphocytic leukaemia (CLL) and mantle cell lymphoma. In July 2009, the EMEA also granted orphan drug designation to blinatumomab for the treatment of ALL.
The drug received accelerated approval from the US Food and Drug Administration (FDA) in March 2018 and full marketing authorisation from the European Commission (EC) in June 2018.
The FDA initially granted full approved to the drug to treat patients with Philadelphia chromosome (Ph)-negative and -positive relapsed or refractory positive B-cell precursor ALL in July 2017.
Lymphoma is a form of blood cancer that arises in the lymphatic system. In lymphoma, lymphocytes start reproducing in an abnormal manner, pile up and gather in some parts of the lymphatic system such as the lymph nodes. The affected lymphocytes lose their infection-fighting capabilities, making them vulnerable to infection.
Although the exact causes of lymphoma are still unknown, several factors have been linked to an increased risk of developing lymphoma. These factors include age, infection with HIV, medical conditions weakening the immune system, exposure to toxic chemicals, and genetics. However, it is unclear as to what role these factors play in the development of lymphoma.
According to the National Cancer Institute, approximately 5,960 people in the US will be diagnosed with ALL in 2018 out of which approximately 1,470 will die from the disease.
Blincyto® is a monoclonal antibody (a type of protein) that contains four immunoglobulin variable domains arranged into a single polypeptide chain. Two of the variable domains build the binding site for CD19, a cell surface antigen found on many of the B cells and B tumour cells. The other two variable domains build the binding site for the CD3 complex on T cells. The CD3 complex is responsible for the activation of the T cells. Micromet used its Bispecific T Cell Engager (BiTE) technology to create the drug by fermentation with eukaryotic cells.
Blincyto® works by targeting CD19 on B cells and using T cells to eliminate the cancer cells. The drug is available for injection as 35mcg of lyophilised powder in a single-dose vial for reconstitution.
The FDA’s previous approval was based on a single-arm clinical trial, in which the efficacy of Blincyto® was studied in 86 patients with Philadelphia chromosome-positive ALL based on the achievement of undetectable minimal residual disease (MRD) method that could detect at least one cancer cell in 10,000 cells in the bone marrow after treatment with one cycle of Blincyto®.
A total of 70 patients achieved undetectable MRD and nearly 50% of patients remained alive and in remission for up to 22.3 months. Additionally, haematological relapse-free survival was also evaluated during the study.
The most common side effects reported in patients during the clinical trial include infections, fever, headache, infusion-related reactions, neutropenia, anaemia, low levels of platelets, neutropenia, and fever.
The safety profile of Blincyto® in 405 adult patients with Ph-negative relapsed or refractory B-cell precursor ALL was studied in a Phase III randomised, open-label, active-controlled clinical study (Phase III TOWER study).
Blicyto showed significant improvement in median overall survival (OS) compared to standard of care (SOC) chemotherapy during the study. The median OS of patients receiving Blincyto® was 7.7 months as compared to only four months for those on chemotherapy.
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