U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for OJEMDA™ (tovorafenib) to Treat the Most Common Form of Childhood Brain Tumor in Pediatric Patients

Original from: Foundation Medicine

Foundation Medicine, Inc. today announced that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne®CDx to be used as a companion diagnostic for Day One Biopharmaceuticals’ OJEMDA, a type II RAF inhibitor, for the treatment of patients six months of age and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring a BRAF fusion or rearrangement, or BRAF V600 mutation. FoundationOne CDx is the first and only companion diagnostic for OJEMDA.

pLGG is the most common brain tumor diagnosed in children.1,2 In this patient population, a BRAF alteration is detected in up to 75 percent of cases. Previously, no FDA-approved treatment options were available targeting tumors harboring BRAF fusions, which represent 80% of BRAF altered patients.3,4,5,6,7

“Foundation Medicine is proud to partner with Day One to help healthcare providers connect pediatric patients and families with this treatment option,” said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. “Our high-quality tissue-based companion diagnostic test is uniquely capable of detecting both BRAF V600 mutations and fusions which enables providers to gain the complete genomic picture of their patient’s tumor and guide treatment decision making.”

Foundation Medicine has sequenced over 2,200 pediatric central nervous system tumors8 and is the only company to offer both tissue and blood-based comprehensive genomic profiling tests that are approved by the FDA. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes in a patient’s tumor. Foundation Medicine is the global leader in approved companion diagnostic indications. Foundation Medicine also has 50% of all approved companion diagnostic indications for next-generation sequencing (NGS) testing in the United States and Japan.9,10

“Historically, pediatric patients with pLGG have faced overwhelming side effects, both near- and long-term, from aggressive treatments like chemotherapy and radiation,” said David Arons, president and chief executive officer at the National Brain Tumor Society. “We are thrilled to see that there are now additional treatment options available for these children, as well as an FDA-approved companion diagnostic test to help identify more patients who may benefit from Day One’s therapy.”

Source: U.S. Food and Drug Administration Approves FoundationOne®CDx as a Companion Diagnostic for OJEMDA™ (tovorafenib) to Treat the Most Common Form of Childhood Brain Tumor in Pediatric Patients