The FDA advised the regulator to approve the use of the country's first drug with a cancer treatment method using genetically modified patient cells (gene therapy). The American media called this event "a window into a new era of medicine".

The drug produced by the Swiss company Novartis, submitted to the FDA, is designed to combat acute lymphoblastic leukemia - blood cancer in children and young adults. B-cell lymphoblastic leukemia is the most common type of cancer among American children. If the FDA approves the Novartis gene therapy device, then very young patients aged 3 years will be able to use it.

Although the regulator is not required to implement the recommendations of the Advisory Board, experts consider the chances that the drug will be approved, as very high. The final decision is expected in September 2017, writes forumdaily.

The essence of the therapy, called CTL019, is that the patient takes his own T-cells (which form part of the immune system), freezes them, takes them to a pharmaceutical company plant, and inserts a gene that helps to kill malignant cells using a specially modified human immunodeficiency virus Cells (this may take several weeks), they are frozen again, taken to the clinic and injected back to the patient.

It is assumed that initially such treatment will be available only in 30-35 American hospitals. There will work specially trained staff, including company employees. Over time, according to representatives of Novartis, CTL019 will be introduced in other countries.

In studies, gene therapy showed promising results: in 29 patients from 2015 or 2016 there are no signs of disease, 11 people had a relapse, 11 underwent additional treatment. Therapy can not be called completely safe:

in some patients it causes flu-like symptoms (sometimes quite serious) and convulsive attacks. Therefore, such therapy is planned to be used when standard treatment does not work, and therefore such side effects are considered justified.

The company does not disclose the future cost of therapy, but it is estimated that it will be about 300 thousand dollars.

Novartis is currently working on other gene therapy products - including for the treatment of multiple myeloma, affecting the bone marrow, and brain tumors.