François-Clément Bidard, François-Clément Bidard, Head of Center for Clinical Investigation CIC-2501 at Inserm, shared a post on LinkedIn:
“EMA’s CHMP approves camizestrant based on SERENA-6.
The EU is now endorsing an adaptive treatment strategy to tackle emerging resistance, based on ctDNA and before clinical progression occurs.
A quiet but important shift in how we treat metastatic breast cancer.
What’s next:
- New SERENA-6 data at ASCO26 (François-Clément Bidard et al, LBA1007, oral session, Tuesday).
Several other ctDNA monitoring studies in mBC will be presented, including a noteworthy retrospective analysis of PADA-1 using an MRD assay (Luc Cabel et al, 3050, poster session, Monday). Together with the recent SMART study (Pedram Razavi et al, ESMO Breast 26) and other results from various teams, this is building a remarkably consistent body of evidence. - The long road to real-world EU access will continue. Availability will vary across countries (France, Germany, Spain, Italy, Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Hungary, Ireland, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Sweden, Norway, Iceland, Liechtenstein, +/- United Kingdom), mostly driven by pricing and national policies.
- US FDA and Japan PMDA decisions are still pending.
Regulatory agencies speak together – but seeing how different systems will assess this first-in-class approach to resistance, initially pioneered in Unicancer’s PADA-1 trial, will be particularly interesting.”
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