(ANSA) – ROME – Breakthrough in cancer treatment. The Food and Drug Administration (FDA) has approved the combined use of dabrafenib (Tafinlar) plus trametinib (Mekinist) for the treatment of adult and pediatric patients 6 years of age and older with unresectable or metastatic solid tumors with a mutation BRAF V600E.
A decision that revolutionizes the world of clinical practice and which in fact recognizes the existence of ‘BRAFoma’ that is – as explained by Giuseppe Palmieri, past president of IMI – Intergruppo Melanoma Italiano, full professor of medical oncology at the University of Sassari, who participated in the discovered this gene and first studied this mutation and its implications – “a target to be treated with therapies regardless of solid tumor type”. BRAF mutations have been identified as growth drivers in more than 20 different types of solid tumors, including rare cancers. “Today we know – says Palmieri – that the V600E variant is responsible for up to 90% of tumors with the BRAF mutation.” In this context, dabrafenib / trametinib is the first and only BRAF / MEK inhibitor combination to be approved with a tumor-agnostic indication and is the only BRAF / MEK inhibitor combination approved for use in pediatric patients.
“A historic decision”, comments Palmieri who adds: “in our studies we have always maintained that it was possible to treat the mutation and not the tumor. Although we knew that BRAF V600E was typical of melanoma, we were convinced that it could absolutely be a target marker for therapies and that other solid tumors could also benefit from the same therapeutic successes. ” Hence the appeal: “As IMI – he concludes – given our experience, we hope that EMA and AIFA will soon acknowledge this decision and that the BRAF test will become a routine diagnostic step to allow a new option for treatment to all patients with solid tumors “. (HANDLE).
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