In the US, cancer will be treated with genetically modified cells
An advisory panel to the US Food and Drug Administration (FDA) has recommended that the regulator approve the country's first drug that treats cancer using genetically modified cells from a patient (gene therapy). The American media called this event “a window into a new era of medicine.”
The preparation of the production of the Swiss company Novartis, submitted to the FDA for review, is designed to fight acute lymphoblastic leukemia, a blood cancer in children and young adults. B-cell lymphoblastic leukemia is the most common cancer among American children. If the FDA approves a gene therapy Novartis, it can be used by quite young patients from the age of 3.
Although the regulator is not obliged to comply with the recommendations of the Advisory Board, experts regard the chances that the drug will be approved as very high. The final decision is expected in September 2017.
The essence of the therapy, called CTL019, is that the patient is taken his own T-cells (which are part of the immune system), frozen, transported to the plant of the pharmaceutical company, using a specially modified human immunodeficiency virus is placed in them a gene that helps kill malignant the cells (this may take several weeks) are frozen again, taken to the clinic and injected back into the patient.
It is assumed that initially such treatment will be available only in 30 – 35 American hospitals. Specially trained personnel, including company employees, will work there. Over time, according to representatives Novartis, CTL019 will be implemented in other countries.
In studies, gene therapy showed promising results: 29 patients with 2015 or 2016 had no signs of disease, 11 had a relapse, and 11 underwent additional treatment. Therapy cannot be called completely safe: in some patients it causes flu-like symptoms (sometimes quite serious) and convulsive seizures. Therefore, this therapy is planned to be used when the 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 drugs, including for the treatment of multiple myeloma, which affects the bone marrow, and brain tumors.
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