Approved for use in the country since 2014, the drug is indicated for advanced cases of a type of cancer called HER2-positive
It was released earlier this week Official Union agendaan ordinance incorporating the drug trastuzumab emtansine, or TDMI-1, al Single health system (SUS). The substance is used for the treatment of breast cancer in Brazil since 2014, when it received approval from National Health Surveillance Agency (Anvisa). The drug does not cause some of the side effects associated with cancer treatment, such as hair loss, but it does require treatment. There is still no information on when the object will reach the health network.
TDMI-1 is indicated for advanced cases of a type of cancer called HER2-positive, in which cancer cells have high levels of the HER2 protein and tend to spread more rapidly. According to the Ministry of Health, the drug has been evaluated by the National Commission for the Incorporation of Technologies into the Unified Health System (Conitec), which advises the portfolio on the incorporation, exclusion or alteration of health technologies by the SUS.
The cases in which there is amplification of the protein correspond to between 20% and 30% of invasive breast tumors and the differential of the drug trastuzumab emtansine is its direct action on the HER2 protein. According to oncologist Laura Testa, a member of the Breast Cancer Committee of the Brazilian Society of Clinical Oncology (SBOC), it is a compound called a drug-antibody conjugate.
“It is an anti-HER2 antibody, which will specifically bind to this protein and has a chemotherapy conjugate. This substance applied directly into a vein is very toxic, but together with the antibody is it delivered directly to the cell that is expressing HER2 ?, Once inside the cancer cell, it inhibits the production of a protein necessary for that cell to continue replicating.
When is the drug used?
There are two scenarios in which patients can benefit from the use of TDMI-1. The former occurs when other types of drugs have not been able to stop the progression of the disease, which has spread in a process called metastasis. The other includes cases in which, after chemotherapy and surgery, there are still residues of the disease and risks of possible metastasis.
According to the oncologist, the treatment usually has good tolerance levels. “Patients usually have good disease control and end up having fewer side effects than chemotherapy, for example. And for patients with post-neoadjuvant residual disease, it really reduces the risk of metastasis in the future,” she explains.
For Michelle Samora, oncologist at HCor, “it is very important that we have a drug in SUS which, when it is shown that chemotherapy in the initial scenario was not able to eliminate the tumor, has a more potent drug so that we increase the chances. of improvement for this patient “. Studies show that the chances of disease recurrence in people who have not been treated with TDMI-1 are up to 50% higher than in people who have been treated with other HER2 inhibitors.
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Trastuzumab emtansine was the first with its operational mechanism approved in Brazil. Since its registration, other drug-antibody conjugates on the market have demonstrated even greater response levels, but all have remained limited to additional health. “Late incorporation into SUS equates treating SUS patients to what supplemental health patients have access to today. It was something that was missing,” says Laura.
The technology does not cause some of the side effects associated with cancer treatment, such as hair loss, but requires close monitoring by medical personnel. Risks include decreased platelets, anemia, and impaired liver function. “In some cases it is also necessary to control the pressure, in addition to having neuropathy (damage to the nerves) that we know is associated with drug use, “Michelle lists.
Currently, people with HER2-positive breast cancer who are treated with SUS are treated with chemotherapy agents and trastuzumab, an anti-HER2 compound made up of part of the trastuzumab emtansine molecule and indicated for the early stages of the disease.
Breast cancer in numbers
The World Health Organization (WHO) considers breast cancer a global public health problem and estimates that, in 2018, 627,000 women worldwide died from the disease, the incidence of which tends to increase as the population ages. .
In Brazil, according to information from the Ministry of Health, the total number of new diagnoses per year reaches 60,000, with an incidence rate of 60 cases per 100,000 inhabitants. In 2018, the country was fourth in the number of cases and fifth in mortality.
Source: Terra
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