The Haute Autorité de Santé (HAS) has just authorized early access to a drug, Trodelvy, for women with aggressive triple negative breast cancer, whose previous treatments have not worked.
The Trodelvy
HAS tells us that Trodelvy is an antibody treatment combined with chemotherapy. Manufactured by the American laboratory Gilead, the drug could already be administered on a case-by-case basis at the request of a doctor as well as by the National Medicines Safety Agency since November 2020. The required conditions were in particular that the patient had already received two other types of treatment, without responding favorably. On July 1, its use was authorized for a very limited number of patients with a therapeutic impasse. Although its placing on the pharmaceutical market is still not authorized in France, Gilead has applied for early access because ” these provisions are not sufficient to cover the needs of all patients. ”
Indeed, this type of breast cancer represents on average 15% of cases in France, or about 9,000 patients per year. As indicated by the HAS, the different therapies “ to treat it are rare and often ineffective. “Trodelvy is a therapeutic option for many women, hence this exceptional new organization to allow them to have access to this treatment before the marketing authorization.
“An absolute gain of 4 months of survival”
The Trodelvy represents a beacon of hope for women with this more aggressive type of breast cancer, whose “ 5-year survival rate of 11.3%. This debilitating disease strongly impacts the social, emotional, family and professional life of the patient. In the phase III study, which compared the efficacy and safety of the drug compared to chemotherapy, “ median survival […] was 5.6 months in the group including Trodelvy versus 1.7 months with chemotherapy. In addition, the results demonstrated an absolute gain in survival of almost 4 months. Therefore, the drug will be available for one year, which ” should make it possible to meet the needs of all the patients concerned while awaiting the completion of the procedure for obtaining a marketing authorization. “
