Italy First in Europe to Approve Colon-Rectal Cancer Treatment That Doubles Survival
Italy has become the first country in Europe to grant access, through its national healthcare service, to a fresh therapeutic combination for patients with metastatic colon-rectal cancer with BRAF mutations – one of the most aggressive and unfavorable forms of the disease. The treatment has demonstrated a doubling of survival rates compared to standard care, offering new hope for approximately 800 people in Italy each year.
The innovative approach combines two targeted molecular drugs, encorafenib and cetuximab, with traditional chemotherapy. Previously considered a “last resort” option, this combination is now being positioned as a first-line therapy. This shift in treatment strategy represents a significant advancement in managing this challenging cancer, which affects around 48,000 people annually in Italy.
According to Corriere Nazionale, the Italian Medicines Agency (AIFA) expedited the approval process, utilizing a procedure established under Law 648/96. This allows for the availability of innovative drugs before formal European Medicines Agency (EMA) approval when there is an urgent clinical demand and compelling scientific evidence.
The AIFA’s decision was announced during the GOIM (Gruppo Oncologico Italia Meridionale) congress in Bari. The approval means that 8-10% of patients with metastatic disease carrying the BRAF mutation will be eligible for this new treatment. The findings could significantly improve outcomes for a subset of patients facing a particularly difficult diagnosis.
While Europe awaits formal EMA clearance, Italy’s proactive step underscores the potential of accelerated access pathways for life-saving therapies. Pharmastar reports that the combination therapy extends median overall survival from approximately 15-16 months to over 30 months.
La Gazzetta dello Sport highlights that this development is particularly key given the aggressive nature of BRAF-mutated colon-rectal cancer. The update underscores the importance of continued research and innovation in cancer treatment to improve patient outcomes.
insalutenews.it also reported on the approval, noting Italy’s leadership in providing access to this new treatment.
