Foundation Medicine Inc., announced that it has received approval from the U.S. Food and Drug Administration for FoundationOne Liquid CDx to be used as a companion diagnostic for BRAFTOVI in combination with cetuximab which is currently FDA-approved for adult patients with previously treated metastatic colorectal cancer harboring a BRAF V600E alteration.
This now makes FoundationOne Liquid CDx the only comprehensive genomic profiling test FDA-approved to identify patients with BRAF V600E alterations in mCRC who may be appropriate for treatment with BRAFTOVI in combination with cetuximab.
Colorectal cancer is one of the most common and deadly cancers globally. BRAF V600E alterations are estimated to occur in approximately 8% of patients with metastatic CRC. Historically, there have been limited treatment options available, so patients with this condition generally face a poor prognosis. 3-4 Pfizer’s BRAFTOVI in combination with cetuximab is the first and only FDA-approved targeted therapy regimen for adults with BRAF V600E-mutated mCRC after prior therapy.
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From a simple blood sample, FoundationOne Liquid CDx analyzes more than 300 cancer-related genes to provide genomic insights. The test has several companion diagnostic indications across non-small cell lung cancer (NSCLC), breast cancer, and colorectal cancer, plus a pan tumor indication specific to NTRK1/2/3 fusions.
“Companion diagnostics are high-quality, well-validated genomic tests that provide critical information to help oncologists make informed treatment decisions for their patients,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “This new companion diagnostic indication for FoundationOne Liquid CDx provides oncologists with an important, non-invasive genomic testing option for metastatic patients with this difficult to treat condition.”
“As the second leading cause of cancer-related deaths for men and women combined, colorectal cancer has had a devastating impact on so many people,” said Michael Salienza, CEO at Colorectal Cancer Alliance. “We’re encouraged by the ongoing progress happening in colorectal cancer care, and believe this approval is an important milestone in delivering broader access to more treatment options.”
SOURCE: BusinessWire