A relief for many patients so far in a therapeutic impasse. Patients with an aggressive form of breast cancer – known as “triple negative” – on which current drugs have no effect may exceptionally receive a new treatment which is not yet authorized, the High Authority for Health announced on Monday. (HAS). This is an antibody treatment combined with chemotherapy, Trodelvy (Gilead laboratory).
“This drug, which does not yet have a marketing authorization, could provide a solution for many patients,” HAS said in a statement.
Aggressive cancer with few effective treatment options
Access is open to all people with triple negative breast cancer who are “treatment failure” after at least two other treatments.
A particularly aggressive form of the disease, triple negative breast cancer is the least common, but represents about 15% of cases, or some 9,000 people each year, recalls the HAS. The 5-year survival rate is 11.3% and the therapeutic options to treat this cancer “are rare and often ineffective”, continues the instance.
Since last year, Trodelvy (sacituzumab govitecan) could be prescribed by name to patients “presenting with metastatic triple negative breast cancer” and having received at least two other types of treatment. But “these provisions are not sufficient to cover the needs of all patients,” said the HAS to justify its decision to expand access, after a positive opinion from the drug agency (ANSM).
“The efficacy and safety data highlight an absolute gain in survival of almost 4 months”, underlines the HAS.
This exceptional procedure is called “early access authorization”. It concerns serious, rare or disabling diseases which require urgent care but for which there is no appropriate treatment.
Provision within two months
The HAS grants an early access authorization to Trodelvy for one year, “which implies that the treatment is made available by the laboratory within two months”. “The duration of this early access authorization 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”, estimated the HAS.
For its part, the ANSM specified that Trodelvy was subject to “an accelerated marketing authorization assessment (AMM) by the European Medicines Agency (EMA)”.