Trodelvy, the new treatment against breast cancer available in France

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HEALTH – Hundreds of women with severe breast cancer have access to Trodelvy since Monday, November 1, an innovative treatment that extends survival by several months: ‘HOPE’, while waiting for other treatments.

France was the first European country that was able to benefit a small number of patients while waiting for production to increase; I can confirm that it will be approved for early access and will be available in France from November 1, 2021.” Health Minister Olivier Veran announced on October 5.

While it is common knowledge that breast cancer is now well treatable, this is not the case with so-called “triple negative” cancer, which affects about 15% of patients, or 9,000 new cases annually. Characteristics: It has no mark (hormone receptor or HER2 protein) on the surface of cancer cells, likely to respond to current targeted therapy. The risk of recurrence is high: 30% within three years of diagnosis.

In the case of recurrent metastases, the prognosis for this cancer has not improved over the past 20 years due to a lack of effective treatments: the five-year survival rate is 11.3%. Affected women are often smaller than average (40% less than 40).

This new treatment is an antibody therapy combined with chemotherapy, manufactured by the American laboratory Gilead, that targets women “who have treatment failure” after they have already received two other treatments.

Study results showed that median progression-free survival for these tumors increased by four months and median overall survival doubled (12.1 months, compared to 6.7 months with chemotherapy).

“This is a real advance, we have not had such good results in this case of metastatic triple-negative breast cancer,” confirmsFrance Press agency Delphine Loirett, M.D., a medical oncologist at the Curie Institute and principal investigator on the ASCENT study, which evaluated this treatment.

“Urgent need”

So far, the Pending Marketing Authorization (AMM) by the European Medicines Agency – which has just been granted – has been granted nominal temporary authorizations for use (ATU) in France, and only a few dozen women have benefited from it.

But then the country faced a supply problem.

“Thanks to the combined mobilization of many actors (associations, oncologists, politicians, media, etc.), we got early access to the laboratory for all patients who needed it,” welcomes Isabelle Yoldjian, director of pharmacology for gynecology at the National Agency for Medicines and Product Safety. Health (ANSM).

Claude Cottier, 52, a spokesperson for the #Mobilisationtriplettes group, formed less than a year ago by women with triple-negative cancer, can only applaud the result of this “collective work”: “A recent survey showed us that about 600 women are in dire need of Trodelvy”.

“Families will be able to stay together longer, which gives hope that other treatments will arrive,” she says.

We want to support the search.

Because, like other tumors, metastatic triple-negative breast cancer cannot be cured.

“We want to support research, so far innovative treatments for this cancer are almost non-existent, except for clinical trials,” Claude Cottier recalls.

Among the programs underway in France, the Mondrian Clinical Trial of the Institut Curie was launched to be able to estimate whether or not triple negative breast cancer responds to chemotherapy and thus save time.

For its part, the Gustave Rossi Institute launched the Compass program, which aims to assess the effectiveness of different combinations of innovative treatments.

Studies have also shown that immunotherapy (a treatment approach that acts on the immune system) improves overall survival for some women with metastatic triple-negative breast cancer.