· Sep 09, 2021

Triple negative breast cancer: HAS authorises Trodelvy for early access

The French National Authority for Health (HAS) has authorised early access to a treatment for metastatic triple-negative breast cancer, Trodelvy (sacituzumab govitecan), for people who have failed two or more lines of systemic treatment. It made its decision on 2 September, following a favourable opinion from the French National Agency for the Safety of Medicines and Health Products on its presumed benefit-risk ratio. 

In France, triple-negative breast cancer (TNBC) is the least common subtype of breast cancer but accounts for about 15% of cases, or about 9,000 people each year. Treatment options are scarce and often not very effective.


Trodelvy fully meets the 4 criteria for early access approval:

  • Trodelvy is intended to treat a serious and debilitating disease. Triple-negative breast cancer is a fatal disease with a median overall survival of 14.5 months and a 5-year survival rate of 11.3%. In addition, it is a disabling disease with a major impact on social, emotional, family and professional life, including pain, deterioration of general health, chronic fatigue, depression and loss of independence.
  • There are no other appropriate treatments for the indication selected for Trodelvy.
  • The HAS also considers that the implementation of the treatment cannot be deferred since it is a specific cancer treatment with curative aims for a disease whose vital prognosis in the advanced stage is committed in the short term.
  • Trodelvy, in the indication under consideration, is likely to be innovative as it is a new modality of disease management bringing a substantial change in efficacy to patients and the drug has an appropriate development plan.


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