Aged 35, Aude has metastatic breast cancer, an aggressive cancer that is difficult to cure. “My life expectancy is limited. The current treatments will not allow me to watch my 3-year-old boy grow up ”, she says in a video addressed to Daniel O’Day, CEO of the American laboratory Gilead Sciences, through the website of the RoseUp association. There are many patient testimonials.
This breast cancer is said to be “triple negative” because it does not express any surface hormone-dependent receptor for estrogen, progesterone or HER2, frequently found in breast cancers. It accounts for about 15% of these tumors, or about 9,000 new cases per year. They are often young women, with small children. The disease is difficult to manage, the recurrence rate is often high.
Like others, Aude asks to have access to Trodelvy (sacituzumab govitecan), which is intended for women who have already received two types of chemotherapy, and often in a therapeutic impasse. This medicine, which combines a monoclonal antibody with chemotherapy, has been marketed since April 2020 in the United States. Filed in March, the marketing authorization (AMM) is being evaluated at the European Medicines Agency (EMA), as part of an accelerated procedure.
A process quickly stopped
In the meantime, in France, The National Medicines Safety Agency (ANSM) granted nominative temporary authorizations for use (ATU) at the end of 2020. But the agency very quickly encountered a supply problem at the end of January, and had to stop this process. “Gilead told us that its production capacity was insufficient and did not allow the start of new treatments outside the United States”, indicates the ANSM. However, an early access device by cohort ATU “Will be set up in December 2021 to take care of a larger number of patients”, promises the ANSM.
The American laboratory Gilead bought, in October 2020 and for 17.7 billion euros, the biotechnology company Immunomedics which manufactured the Trodelvy. “This small company was integrated at the end of 2020, but given the nature of the drug, which is complex to produce, availability for Europe is expected at the end of the year”, explains Michel Joly, president of Gilead France.
Since the start of the year, the ANSM, patient associations, the group of women #Mobilisationtriplettes, oncologists … all have fought with the laboratory to obtain, at the beginning of June, new access to the drug, allowing France to ‘“To be the only country to have this little extra”, notes the ANSM. “This treatment appears to be an important step forward for patients with a very poor prognosis. We are fighting so that all these eligible women can benefit from it ”, indicates Dr. Isabelle Yoldjian, head of the medical drugs department at the ANSM. But it will be trickle down. Sixty-four patients had received ATUs in France in January and, in total, only seventy-eight women will be able to benefit from them.
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