FDA OK’s diagnostic test to identify pediatric cancer patients for Ojemda
FoundationOne CDx is designed to detect mutations in BRAF gene
The U.S. Food and Drug Administration (FDA) has approved FoundationOne CDx, Foundation Medicine’s companion diagnostic test to help identify if patients with pediatric low-grade glioma can benefit from treatment with Ojemda (tovorafenib).
FoundationOne CDx analyzes more than 300 cancer-related genes in tumors from children with relapsed or refractory low-grade glioma to detect mutations in the BRAF gene, which is commonly altered in these patients. The test can help connect pediatric patients who have BRAF gene changes with particular targeted treatment options, specifically Ojemda, Day One Biopharaceuticals’ FDA-approved oral treatment for pediatric low-grade glioma.
“Foundation Medicine is proud to partner with Day One to help healthcare providers connect pediatric patients and families with this treatment option,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine said in a company press release.
Pediatric low-grade gliomas (pLGGs) are slow-growing tumors that affect the brain and spinal cord in children. The tumors are the most frequently diagnosed type of brain cancer in pediatric patients. In up to 75% of cases, patients will have an alteration to the BRAF gene, which provides instruction for making a protein that controls cell growth. When BRAF is mutated, it can cause cells to divide uncontrollably, which leads to several types of cancer, including LGGs.
There are two common types of mutations that occur in the BRAF gene: the V600E mutation and BRAF fusions. In the V600E mutation, a specific part of the BRAF protein changes, causing it to behave abnormally. A fusion occurs when the BRAF gene gets rearranged or swapped with other genes on chromosomes. Both mutation types can contribute to developing various cancers.
Diagnostic for treatment with Ojemda
Ojemda is an FDA-approved oral targeted therapy for children ages 6 months or older with pediatric LGG. To be treated with Ojemda, patients must have either a V600E mutation or fusion in the BRAF gene and have LGGs that didn’t respond to treatment (refractory) or returned after treatment (relapsed). Ojemda works by blocking the activity of the mutant BRAF protein and other related proteins.
As a companion diagnostic, Foundation CDx detects different types of mutations in 324 genes in DNA from tumor tissue. Doctors can then match the patient to different targeted treatments based on the biomarker, or mutation, detected. Foundation Medicine has analyzed the DNA sequences of more than 2,200 pediatric brain and spinal cord tumors, the press release notes.
With this new FDA approval, the Foundation CDx sequencing technology can be used to detect if tumors from children with LGG are positive for either the V600E BRAF mutation or a BRAF fusion, and could therefore be eligible for treatment with Ojemda.
“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,” Levy said.
According to the company, Foundation CDx is the first and only companion diagnostic for Ojemda.
“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.”
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