Anti-cancer therapy that risks having the opposite effect

The first to raise the alarm, last November, was the Food and Drug Administration (FDA). The agency that regulates drugs and foods in the United States has in fact warned, through a note, about the …

Anti-cancer therapy that risks having the opposite effect

The first to raise the alarm, last November, was the Food and Drug Administration (FDA). The agency that regulates drugs and foods in the United States has in fact warned, through a note, about the risk of secondary tumors associated with Car-T cell therapy (acronym for “Chimeric antigen receptor T-cell”), the most advanced form of anticancer therapy. At the beginning of the year, for the same reason, the European Medicines Agency (EMA) also announced the start of a process to review the safety of CAR-T therapies (there are currently six approved procedures in Europe: Abecma, Breyanzi, Carvykti, Kymriah, Tecartus and Yescarta).

Now the Italian Medicines Agency (Aifa) publishes the extract of the meeting of the Committee for the evaluation of risks in pharmacovigilance (Prac) of the European Medicines Agency (EMA), in which it warns that “patients treated with medicines based on Car-T cells must be monitored throughout life for possible secondary neoplasms”. The review of the literature, supported by research published in the New England Journal of Medicine, therefore does not exclude a risk never denied by the manufacturing companies themselves. Expressed since the green light, in 2017, for the first Car-T therapies.

Patients monitored for life

In detail, the PRAC evaluated the data acquired from approximately 42,500 cancer patients treated with CAR-T-based therapies, hailed seven years ago as a turning point (“We are entering a new frontier of medical innovation, with the opportunity to reprogram the patient’s cells to attack a deadly tumor”, the words of the then FDA commissioner, Scott Gottlieb). There were 38 cases of secondary malignant tumors detected, confirmed – in 7 cases – by detecting the chimeric antigen receptor (Car-T cells) within the tumor tissue sample.

And it is proof, according to the experts of the EMA committee, of the link between the administration of the treatment and the onset of a secondary neoplasm. These secondary tumors have been reported over a rather broad time span: from a few weeks up to several years after treatment with Car-T. Hence the recommendation – also strengthened by a study published in the New England Journal of Medicine – to monitor the health of patients treated with CAR-T through lifelong monitoring.

How Car-T therapies work

Personalized immunotherapy in which the cells of the immune system (T lymphocytes) are taken from a person with cancer and genetically modified in the laboratory – so that, once transplanted to the same patient from which they were taken, they can attack the neoplasm – Car therapies -T I’m a “living drug”. Characterized by a complex preparation, this approach offers a treatment opportunity for patients suffering from oncohaematological pathologies (myeloma, leukemia, lymphoma) who have relapsed following one or more traditional therapies.

Car-T therapies are therefore the last option when conventional treatments – such as chemotherapy and radiotherapy – do not work. Although they do not lead to cure, these procedures have shown important results against some of the most complicated tumors to deal with. As Nature explains, depending on the type of cancer, up to two thirds of patients and more went into remission after being treated with Car-T.