Foundation Medicine Inc. has obtained U.S. Food and Drug Administration (FDA) approval for its FoundationOne®CDx as a companion diagnostic tool for Eli Lilly and Company’s drug, Retevmo (selpercatinib). Retevmo is FDA-approved for treating adult patients with advanced or metastatic solid tumors having a RET gene fusion, either post-systemic treatment or when no other effective treatments are available. This approval marks a significant milestone in oncological advancements.
The FoundationOne CDx test examines over 300 genes associated with cancer to identify genomic changes in a patient’s tumor tissue. This data-driven approach facilitates customized treatment plans and helps determine the suitability of Retevmo for patients with RET gene fusions, which are present in less than two percent of solid tumors.
Mia Levy, Chief Medical Officer at Foundation Medicine, highlighted the increasing demand for effective solutions for patients with uncommon gene fusions. Levy emphasized that high-quality companion diagnostics are pivotal in furnishing oncologists with essential data for the crafting of individualized treatment strategies. She also pointed out that Foundation Medicine has effectively maneuvered through the intricacies of obtaining pan-tumor approval. The organization takes pride in adding another companion diagnostic to its existing FDA-approved tissue test portfolio. This addition aims to facilitate more comprehensive access to pivotal therapy options for patients with RET-fusion positive solid tumors.
Source: U.S. Food and Drug Administration (FDA) Approves FoundationOne®CDx as a Companion Diagnostic for Lilly’s Retevmo® (selpercatinib) for Certain Patients with Solid Tumors.
https://www.foundationmedicine.com/press-releases/0a64663c-41b5-412f-86c1-fa2399db880e
