FDA granted Breakthrough Therapy Designation (BTD) to plixorafenib for the treatment of adult patients with BRAF V600E-mutated high-grade glioma (HGG)
“The granting of Breakthrough Therapy Designation is a significant development milestone for plixorafenib and reinforces our conviction in its unique mechanism of action which, further supported by the tolerability and efficacy profile seen in BRAF-altered tumors, underscores the potential of plixorafenib as a treatment option for patients living with difficult to treat cancers,” said Stacie Peacock Shepherd, M.D., Ph.D., Chief Medical Officer of Fore. “BRAF alterations are an important actionable driver in the molecularly integrated clinical decision paradigm for the treatment of high-grade gliomas, and plixorafenib has demonstrated a differentiated profile in patients with primary CNS tumors, including glioblastoma and other high-grade gliomas. The maturation of the data from FORTE may help validate these findings, with BTD status further accelerating the delivery of this promising therapy to patients. We look forward to continued collaboration with the FDA to further advance plixorafenib and to advancing our FORTE basket trial in several types of BRAF altered malignancies.”
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