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FDA Approves FoundationOne CDx for Eli Lilly's Retevmo

NEW YORK – Roche subsidiary Foundation Medicine announced on Monday that its tissue-based FoundationOne CDx assay has been approved by the US Food and Drug Administration for use with Eli Lilly's Retevmo (selpercatinib). 

Retevmo was approved by the agency in 2022 for the treatment of adult patients with locally advanced or metastatic solid tumors with RET gene fusions that have progressed on previous systemic treatment or who have no alternative treatment options. The next-generation sequencing-based test analyzes more than 300 genes to detect genomic alterations in tissue samples and can determine if Retevmo is an appropriate treatment option for patients with RET gene fusions, Foundation Medicine said in a statement. According to the company, less than 2 percent of solid tumors have RET gene fusions.

The new approval is the company's fifth pan-tumor approval in the US for FoundationOne CDx, it noted. 

"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," Mia Levy, Foundation's chief medical officer, said in a statement.