
Foundation One Announces FDA Approval for Companion Diagnostic Indication for Retevmo in Cancers With Rare RET Gene Fusions
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 Eli Lilly and Company’s Retevmo (selpercatinib), which was approved by the FDA for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options. Retevmo is primarily used in the treatment of non-small cell lung cancer which, impacts approximately 190,000 patients per year in the U.S. and where 1-2% of patients have RET mutations, and medullary thyroid cancer, which impacts about 1,000 people per year in the U.S., where up to 60% of patients have RET gene fusions.
This announcement marks Foundation Medicine’s fifth pan-tumor approval in the U.S. for FoundationOne CDx, the only tissue test with multiple biomarkers approved as a tumor agnostic companion diagnostic in the U.S., including TMB and NTRK1/2/3. It also marks Foundation Medicine’s ninth approved companion diagnostic indication across 7 different fusion genes (ALK, ROS1, NTRK1, NTRK2, NTRK3, FGFR2, and now RET.)
Using a tissue sample, FoundationOne CDx analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor, which allows a tailored treatment approach and will determine if Retevmo is an appropriate treatment option for patients with RET gene fusions, which occur in less than two percent of solid tumors. The test currently has over 30 companion diagnostic indications, ranging from lung, breast, prostate, colon, and other solid malignancies. The company also has 60% of all U.S. companion diagnostic approvals for next generation sequencing (NGS) testing.
“With a growing need for solutions for patients with rare fusions, high-quality companion diagnostics provide critical information to support oncologists in the development of personalized treatment plans,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “With our experience successfully navigating the complexities of a pan-tumor approval, we’re proud to have another companion diagnostic for our FDA-approved tissue test that can help enable broader access to an important therapy option for RET-fusion positive solid tumors. We appreciate this meaningful collaboration with Lilly to help bring more treatment options to patients facing a cancer diagnosis.”