primary
- Trudelphi, marketed by the Gilead laboratory, which will be urgently allowed on US and French soil in the spring of 2020, should double the life expectancy of women with metastatic triple negative breast cancer.
- But this innovative treatment has struggled to offer it to patients, due to a lack of sufficient production to supply Europe.
- In France, about 600 breast cancer patients are currently awaiting treatment with Trodelvy.
–
In February 2019, A study Published in New England Journal of Medicine Hope increased in women with metastatic triple negative breast cancer, the most aggressive and deadly type of breast cancer. The Immunology Laboratory has detailed the effectiveness of a new treatment that specifically targets a tumor. Called Trodelvy, it does not offer hope for a cure, but rather the hope of extending life expectancy by a few months. “According to official figures, the average survival is 14 months, explanation for Franceinfo Claude Cottier, who announced her battle against triple negative breast cancer. Fourteen months is a short period. So this drug allows life expectancy to be doubled ”.
Trodelvy obtained an emergency license in the United States in April 2020 and is also attracting the attention of the National Agency for the Safety of Medicines and Health Products (ANSM). As of May 2020, this also allows early access to Trodelvy in France under a temporary use authorization (ATU) on a registered basis.
Trodelvy will be available again at the end of the year
But after a few months, it was time for a cold shower. Immunomedics was acquired by Gilead Lab in October 2020 and can no longer produce enough Trodelvy to supply Europe. “We are in the process of developing this capacity for Europe and for other countries elsewhere, outside of the United States, Justify Michel Joly, Gilead President of France, Franceinfo. We will have a medicine that will also be available at the time of obtaining the European marketing authorization, that is, at the end of the year. But in the meantime, realizing the trajectory of the condition of these patients, we were able to take a few thousand bottles of American production to give Trodelvy access to a few dozen patients who are in an emergency situation.
This emergency situation affects 78 patients, whose applications had already been validated by the ANSM before the suspension of the ATU at the end of January. The magazine interviewed him Get upCécile Rabien, French medical director of the Gilead Laboratory, confirmed that the laboratory had engaged with the American Agency for Medicines (ANSM) to take over and “To administer the doses necessary for the continuous treatment of these patients.”
Not enough promise
“78 women, that’s great, but what about the others, did we let them die? What do we do?”asks Claude Cottier, who created the group #MobilisationTriplettes so that all women with metastatic triple negative breast cancer can access treatment. “We are aware that patients and doctors have a great need for our medicines and we are doing everything possible to increase our production capacities, Cecil Rabian continues. As with its anti-Covid drug, Remdesivir, the company is currently looking for partners to help it produce more doses. “
“Our American colleagues are exploring all possible avenues to supply France and all the other countries that claim Trodelvy. There are many routes, but few structures currently capable of producing this drug ”. Also specify the laboratory.
Claude Cottier, for his part, asks the laboratory to agree to supply the drug over the next few months to the 600 French patients who are waiting for them. Half of them are under forty years old. “Young mothers, even pregnant women who discover their own breast cancer. We desperately need solutions, we cannot accept that, we cannot sit idly by, it just isn’t possible. “
READ ANSM launches a campaign to warn of the dangers of some medications during pregnancy
–
