Anvisa approves early use of medicine to treat HER2-positive breast cancer

It can now also be used by patients who have undergone chemotherapy and surgery, but still have cancer cells in the removed tissue and have the HER2 protein, which makes cells multiply faster.

A test measures this protein in the tumor and, when the result is positive, the cancer is classified as HER2-positive.

Those in this group are more likely to have their cancer return and progress to metastasis. According to Anvisa, up to 25% of these patients may relapse within ten years.

Until now, Enhertu was only indicated for more advanced cases of HER2-positive cancer, says mastologist Rosemar Rahal, president of the National Commission Specialized in Mastology at Febrasgo (Brazilian Federation of Gynecology and Obstetrics Associations).

The intention of the new use is to increase patients' chances of being cured, reducing the risk of the cancer returning invasively or of death, says the doctor. The study that supported the approval showed a 53% drop in the risk of the cancer returning or leading to death.

The medicine works as a delivery mechanism, explains Rahal. An antibody recognizes diseased cells and delivers a substance to them that causes tumor death, sparing more healthy cells than common chemotherapy.

The objective of Enhertu, at this point [immediately after surgery], he says, is to eliminate possible remaining tumor cells and increase the probability of definitive control of the disease.

Breast cancer is the most diagnosed cancer in the world and the one that kills the most women due to cancer. In Brazil, there are more than 70 thousand new cases per year. Between 10% and 19% of them are HER2-positive, historically associated with a worse prognosis.

Anvisa's approval allows the use of the medicine in the country, but does not guarantee access through the SUS (Unified Health System). To do this, new approval is needed from Conitec (National Commission for the Incorporation of Technologies into the SUS) and the Ministry of Health.

Conitec is already evaluating the same medicine for two other groups of patients, with more advanced or metastatic cancer. This new indication, for residual disease, is not part of this analysis and is not yet expected to reach the SUS.

Anvisa prohibits online consultation and medication delivery platforms

Anvisa highlighted in a statement that the company responsible for the platform, Revia Gestão de Negócios Ltda., does not have operating authorization for this type of activity