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How is the new drug against 17 types of cancer that was approved in Argentina

2023-02-06T09:32:08.595Z


It's called entrectinib. It is administered orally and is indicated according to the genetic alterations of the tumor.


It is estimated that there are more than 130,000 new cases of cancer per year in Argentina.

The most frequent are those of the

breast, colon-rectum and lung

.

But the advent of new treatment options represent a paradigm shift in the way cancer is diagnosed, studied, and treated.

Because?

Simply because patients can now be treated according to

genomic profiles

and not according to the type or origin of the tumor.

So, instead of treating this disease according to where it is located, it is addressed according to the genetic alteration that the NTRK or ROS1 gene presents.

“Diagnosing the genomic profile of the tumor serves to identify

NTRK and ROS1 gene fusions

and, therefore, determine which patients are most likely to benefit from this treatment.

This type of treatment approach, in combination with high-quality genomic profiling, makes it possible to apply

personalized cancer treatments

”, Claudio Martín, Head of Thoracic Oncology at the Alexander Fleming Institute

, explains to

Clarín .

What is the new therapy about?

Entrectinib is a state-of-the-art drug that is indicated according to the genetic alterations of the tumor regardless of where it is located.

It is imported from the US and is administered

orally

.

It has shown benefits in treating 17 different types of solid tumors, including breast, colon and rectal, lung, pancreatic, head and neck, brain, melanoma and sarcoma in stages with few treatment options until now.

The National Administration of Food, Drugs and Medical Technology (ANMAT) approved the registration of the drug from the firm Roche in 2022 and on January 17, 2023

authorized its commercialization

(it is available to the patient) for any type of solid tumor that presents Specific genetic alterations in the NTRK1, 2 and 3 and ROS1 genes.

Why is it a tumor agnostic therapy?

"Its indication does not depend on which organ the cancer develops in, but rather on whether the tumor has some specific genes altered, called NTRK1, 2 and 3, which occurs in almost 90% of rare tumors," answers Martín, who also He is a member of the Argentine Association of Clinical Oncology (AAOC).

“What is innovative is that

it is not approved for one, two or five types of cancer

.

It is indicated to inhibit the alterations of the NTRK genes that favor the growth of some tumors, regardless of whether they are located in the brain, in the breast or wherever”, distinguishes Martín.

What are genetic alterations?

Most of the rare tumors are located in different organs and cause different symptoms in patients.

However, many are united by the fact that it is

the same genetic alteration

(it can appear in organs, glands and tissues) of the tumor that favors its development and growth.

“These genetic alterations are molecular changes that the tumor presents (they are not hereditary) and that allow the disease to grow.

The change that occurs in a gene called NTRK

determines that the tumor grows through an activation pathway

caused by this gene.

The medication that blocks this gene (entrectinib) generates the

arrest of tumor growth

, ”Martín explains to

Clarín

.

In addition, he adds that entrectinib can also block another of the pathways, the ROS1 gene, present in 1 or 2% of cases of metastatic non-small cell lung cancer.

What is the advantage of these precision therapies?

The fact of the tumor response and the benefit that is given to the patient is greater because the possibility that the medication that is given will work is high.

This is how Martin describes it.

"In this way, the investment made by the system in providing effective medication is more optimized."

The investment we make in a precision therapy, such as entrectinib for ROS1 or NTRAC, we have a high probability that this investment will benefit the patient and their recovery," he adds in dialogue with this medium.

molecular studies

The presence of these genetic alterations is determined through

molecular studies

carried out in the country.

“There are different methods to diagnose them.

The most widely used is genetic sequencing, which evaluates whether the gene is altered.

It is done in various places in Argentina such as Buenos Aires, Córdoba and Rosario”, develops Martín.

And he adds: “Molecular testing today should be a routine study immediately after diagnosis, because it is the key to indicating the most appropriate treatment.

It is that within what is known as precision medicine, identifying the genetic alteration that the tumor presents allows determining the most convenient treatment.

“After decoding the genome of each tumor, we know that if we indicate targeted medication to inhibit this tumor mechanism, we will obtain

better results

than using traditional medications, with less toxicity than chemotherapy and avoiding squandering resources on treatments that will be less effective or that they will make the patient lose valuable and irrecoverable time”, qualifies Martín.

Papers showing clinical benefits

Three clinical studies evaluated the efficacy and safety of the new medication, in patients with different types of cancer and fusions in the NTRK and ROS1 genes.

Of the 150 people with multiple cancers with NTRK fusions treated with entrectinib,

61% had their tumor

shrinkage and 25 had a complete response, ie total tumor removal.

Among those who did shrink their tumors, the median duration of response was

20 months

, even in people with central nervous system metastases.

The progression-free survival was

13.8 months and the overall survival was 37.12

.

"These are more than encouraging results and were unthinkable a short time ago, especially since we are talking about difficult-to-treat tumors and complex diseases in advanced stages," concludes Martín.

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Source: clarin

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