Overview
Release form, packaging and composition of the drug Blinzito
Powder for the preparation of a concentrate for the preparation of an infusion solution in the form of a powder or an amorphous mass of white or light yellow; colorless to light yellow reconstituted solution, transparent or slightly opalescent, free from mechanical impurities; colorless to light yellow stabilizer solution, transparent or slightly opalescent, free from mechanical impurities.
Blinatumomab (tradename Blincyto ) is a biopharmaceutical drug used as a second-line therapy for the Philadelphia chromosome — negative relapsing or refractory acute lymphoblastic leukemia. It belongs to the class of constructed monoclonal antibodies, bi-specific T-cell linkages (bites) that act selectively and direct the human immune system Blincyto act against tumor cells. Blinatumomab is specifically targeted to the CD19 antigen present on B cells. In December 2014, it was approved by the US Food and Drug Administration as part of the accelerated program approval; marketing authorization depends on clinical trial results that were ongoing at the time of approval.
Blinatumomab is given as a continuous intravenous infusion for 28 consecutive days in a single cycle. The dose depends on the actual body weight of the patient. Patients weighing more than 45 kg should receive fixed doses, while patients weighing less than 45 kg should receive doses depending on their estimated body surface area .
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Medical use
Blinatumomab was originally approved for the treatment of Philadelphia chromosome-negative relapsing or refractory precursor to B-cell acute lymphoblastic leukemia in adults and children. It is currently approved by the US FDA for the precursor of B-cell acute lymphoblastic leukemia (ALL) in the first or second complete remission with a minimum residual disease greater than or equal to 0.1%, as well as a relapsing or refractory ALL-cell precursor of ALL .
Mechanism of action
Blinatumomab is a bispecific T-cell Engager (Bite). This allows the patient T - cells to recognize malignant B - cells. The blinatumomab molecule combines two binding sites: a CD3 site for T cells and a CD19 site for target B cells. CD3 is part of the T cell receptor. The drug works by combining these two types of cells and activating T cells - they have cytotoxic activity on target cells. CD3 and CD19 are expressed in both children and adults, making blinatumomab a potential therapeutic option for both children and adults.
story
The drug (originally known as MT103) was developed by German-American company Micromet, Inc. in collaboration with Lonza; In 2012, Micromet was acquired by Amgen, which promoted clinical trials of the drug.
In July 2014, the FDA granted breakthrough treatment status to blinatumomab for the treatment of acute lymphoblastic leukemia (ALL). In October 2014, Amgen's Biologics License Application for blinatumomab was prioritized for an FDA assignment review, thus setting a deadline of May 19, 2015 to complete the FDA review process.
On December 3, 2014, the drug was approved for use in the United States for the treatment of the Philadelphia chromosome — negative relapsing or resistant acute lymphoblastic leukemia under the FDA’s accelerated approval program; marketing authorization depends on clinical trial results that were ongoing at the time of approval.
Cost
When blinatumomab was approved, Amgen announced that the price of the medicine would be $ 178,000 a year, making it the most expensive cancer drug on the market. Merka pembrolizumab was valued at $ 150,000 a year when it started (in September 2014). At the time of initial approval, only about 1,000 patients in the United States had an indication of blinatumomab.
Peter Bach, director of the Center for Health Policy and Outcomes at the Memorial Sloan-Kettering Cancer Center, estimated that according to “cost-based pricing,” provided that the cost of a year of life is $ 121,000 with a 15% toxicity discount ” “The market price of blinaumomab should be $ 12,612 per month, compared with a market price of $ 64,260 per month. An Amgen spokesman said, “Blincyto's price reflects the significant clinical, economic and humanistic value of the product to patients and the healthcare system. The price also reflects the complexity of the development, production and reliable supply of innovative biological medicines. ".
A little over a year ago (December 3, 2014) FDA registered "head" the drug is a new class of immunotropic drugs, which we have already talked a little about on our site. These are bispecific antibodies - molecules that cannot exist in nature. They differ from ordinary antibodies in that they can simultaneously bind to two molecules different antigens.
This medicine has an inconvenient name for the Russian language - BLINATUMOMAB or BLINCYTO®.
Blincyto® developed by Amgen inc. It was registered according to a simplified scheme. (accelerated approval program), which is used in cases where there is evidence that the drug helps patients who no longer have any other medicines. The essence of simplification is that for registration there was enough data from the second phase of the study, and not III, as for conventional drugs.
A year later, on November 23, 2015, Blincyto® was also registered in the European Union.
So far, in the United States and Europe, this medicine is allowed for only one indication - acute lymphoblastic leukemia (ALL), moreover, only for the specific subtype of this disease: pre-B-cell refractory-recurrent ALL without the Philadelphia chromosome (this is the proper name for the mutation).
ALL begins with changes in the genome of lymphocyte progenitor cells. Such cells are called lymphoblasts. Usually they divide and mature into B- and T-lymphocytes, as well as lymphocytes of innate immunity.
However, with ALL, the lymphoblast program changes, and, instead of forming new normal lymphocytes, they begin to multiply themselves uncontrollably. In this case, excessive accumulation of abnormal cells occurs (first in the bone marrow, and then in other tissues) and at the same time a deficiency of normal lymphocytes develops.
Some of these patients can be radically cured by existing standard methods, but for some types of ALL there is no effective therapy. Among these is pre-B-cell ALL, especially the disease that progressed during or after treatment. This is called "refractory-relapsing".
For such patients, Blinatumomab was invented. This name comes from the abbreviation B lineage-specific antitumor mouse monoclonal antibody.
How does it work Blincyto®?
Cytotoxic T-lymphocytes capable of directly killing cells carrying antigens specific to these lymphocytes are responsible for the fight against the body's own cells infected with viruses or tumor cells. For the recognition of Blincyto, a T-lymphocyte has T-cell receptors on the membrane. They bind to peptide fragments of antigens present on the membrane of the target cell in complex with first-class MHC molecules.
