Every year, about 9000 people in France are diagnosed with triple negative breast cancer (TNBC). Uncommon (it represents “only” 15% of breast cancers), this cancer is rather diagnosed in young women: unfortunately, the therapeutic options to treat it are rare and often not very effective.
Good news: this Tuesday, November 5, the Minister of Health, Olivier Véran, announced that Trodelvy®, a new treatment against this aggressive form of cancer, will be authorized for early access and available in France from November 1, 2021. On September 2, the High Authority for Health (HAS) authorized early access to this drug which does not yet have a marketing authorization (AMM) in France but was already prescribed to around 600 French women suffering from a triple negative metastatic breast cancer and “in therapeutic impasse” since the end of 2020.
A doubling of overall survival
efficiency from Trodelvy (the Sacituzumab govitecan) in terms of non-progression of the disease and overall survival had been reported in the context of the international phase 3 clinical study ASCENT, coordinated in France by the Institut Curie. “With a doubling of overall survival, this is the most positive and encouraging result in many years for women with Cancerfrombreast triple negative. I am now convinced that this new class of drug will truly be a game-changer in the years to come.” said Delphine Loiratmedical oncologist at the Institut Curie and principal investigator of the ASCENT study.
Following a favorable opinion issued by the National Agency for the Safety of Medicines and Health Products (ANSM) at the end of August 2021, HAS therefore authorized access to Trodelvy® for “adult patients with triple breast cancer unresectable or metastatic negative, having previously received 2 or more lines of systemic treatment, including at least one of them at the advanced stage”.
It’s a real victory. Indeed, as stated by the HAS in a press release, “the efficacy and tolerance data for Trodelvy® highlight an absolute gain in survival of almost 4 months”. Furthermore, “there are no other appropriate treatments in the indication selected for Trodelvy®”
HAS granted this early access authorization for one year.
Other trials in progress
The Trodelvy, (Sacituzumab govitecan) is also being studied at the Institut Curie for earlier stages of the disease. And other molecules are also being evaluated in triple negative cancers (for example Trastuzumab deruxtecan) or in other types of cancer (hormone-dependent breast cancer, bladder cancer, lung cancer).
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