“Compassionate access.“This is what theNational Medicines Safety Agency (ANSM) is planning from June 3 for Trodelvy (sacituzumab govitecan), a treatment for so-called triple negative breast cancer. It should thus issue temporary authorizations of use (ATU) nominative to about 80 patients in therapeutic impasse, announces the agency in a press release.

This drug, which combines immunotherapy and chemotherapy, improves the living conditions of women with triple negative breast cancer with metastases.

ATUs suspended for six months

If Troveldy has had a marketing authorization (MA) in the United States since April 2020, this is still not the case in Europe where this treatment is being evaluated at the European Medicines Agency. (EMA).

By the end of 2020, 64 patients had received the first ATUs in France. But in January 2021, the laboratory manufacturer Gilead indicated to the ANSM that “its production capacity was insufficient and did not allow the start of new treatment outside the United States“. Result,”in order to ensure continuity of care for women who have already started treatment, new ATU requests have remained pending“until today, recalls the ANSM.

Marketing in 2022?

After this new stage, an early access system by cohort ATU “will then be implemented in December 2021 to take care of a larger number of patients“promises the ANSM.

Finally, the marketing of this drug in Europe should be effective “current 2022“, according to the agency.

14 months of survival without this treatment

A deadline awaited by many patients and families of patients. And for good reason: this cancer represents 15 to 20% of breast cancers and affects more than 11,000 women in France each year, most of them aged 30 to 45 years. It is one of the most aggressive cancers and the most difficult to treat due to the lack of suitable therapeutic solutions. And when metastases form, the median survival is only 14 months in France.

To ask the Gilead laboratory for access to this treatment in France, a group of patients, relatives and families of patients, the Mobilisation Triplettes collective, was launching a petition last April. It has already collected nearly 60,000 signatures.