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Validation of the applications confirms the submission is complete, and the EMA will now begin its review procedure.
“BRAF-mutant mCRC is a devastating cancer, for which there are currently limited treatment options that can prolong the lives of patients. The acceptance of our application by the EMA brings us one step closer to realising our commitment towards advancing care for patients living with difficult-to-treat cancers,” said Jean-Luc Lowinski, CEO of the Pierre Fabre Pharmaceuticals Division. “If approved, Braftovi+Mektovi in combination with cetuximab has the potential to be the first chemotherapy-free, targeted regimen for patients with BRAFV600E-mutant mCRC.”
The application is based on data from the pivotal Phase III BEACON CRC trial. The randomised, open-label, global study evaluates the efficacy and safety of Braftovi+Mektovi in combination with cetuximab in patients with advanced BRAFV600E-mutant mCRC whose disease has progressed after one or two prior lines of therapy. This is a first-of-its-kind study, as the trial is designed to test combined BRAF/MEK targeted therapies in individuals with BRAF-mutant mCRC. Expanded interim results from this trial were previously presented during a late-breaking oral session at the 2019 European Society for Medical Oncology (ESMO) Congress and simultaneously published online in the New England Journal of Medicine in September 2019.
The results of the BEACON CRC trial showed significant improvements in overall survival (OS) and objective response rates (ORR) for Braftovi+Mektovi in combination with cetuximab and Braftovi in combination with cetuximab, compared with cetuximab plus irinotecan-containing regimens. Both combination regimens demonstrated a safety profile with no unexpected toxicities.
Patients with BRAF-mutant CRC generally have a poor prognosis with current available treatments. Currently, there are no approved therapies in Europe specifically indicated for this high medical need population. BRAF mutations are estimated to occur in approximately 8-12% of patients with mCRC, and V600E is the most common mutation.