the basics Hundreds of French women with metastatic triple negative breast cancer need Trodelvy, a drug that can extend their life expectancy. But the American laboratory that markets it does not currently have the capacity to produce and market it in Europe.
There are around 600 French women who see hope in the drug Trodelvy. That they enjoy a little more from their loved ones and deserve a life that is too short a few months. Especially since most women with metastatic triple negative breast cancer are under 40 years of age.
Every year, “1,700 women find out they have come back from metastatic cancer, so access to Trodelvy is a lifelong emergency,” said Claude Coutier, co-founder of Collectif Mobilization Triplettes, which petitioned for access to treatment online. She was also affected by the disease after another relapse of breast cancer at the age of 52.
“The United States has the dose for France!”
Trodelvy “is the only drug available” to help these women with cancer. The treatment doubles life expectancy: from 14 to 28 months, explains Celine Lis Raoux, director of the RoseUp association. “It is the first drug in 20 years to show such an effect. We have been failing for years, ”adds oncologist Suzette Delaloge.
The American drug has passed all clinical studies that give (again) hope to women affected by the disease. “We don’t want to test Perlimpin powder, we know it works, so we want to try. Innovative treatments like Trodelvy won’t cure us, but they will extend life expectancy. It is our life emergency. A call to life, ”chanted Claude Coutier.
But the American laboratory Gilead, which makes the cans, would not have the resources to send them to Europe. “Gilead only has one factory in the US that produces for its territory. We therefore have to wait until the construction of a factory in Italy is sufficiently dosed in Europe ”, regrets Dr. Delalogues.
“Early Access” at the end of 2021?
Problem, the Italian factory is not expected before the end of 2021 … an eternity for these women. “The end of the year is not possible for us! It is terrible!” Claude Coutier desperate.
Celine Lis Raoux, who works as a journalist in addition to her position as director of Roseup, contacted American oncologists: “The United States has enough Trodelvy for its needs, but also those of France and even another country! The idea is now making noise across the Atlantic, there is nothing Gilead France can do, Olivier Véran [le ministre de la Santé] is in contact with them, but it is the big boss Daniel O’Day who decides, “plagues the activist.
On the part of the National Medicines Safety Agency (ANSM), the first Nominal Temporary Approvals (ATU) were granted by Trodelvy in late 2020 to allow treatment of some patients in France who are awaiting treatment. In a press release, the ANSM ensures that “in December 2021, as soon as the laboratory’s production increases, a broader Early Access program will be launched so that patients can fully benefit from this drug”.