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Foundation Medicine, Day One Biopharmaceuticals to Develop CDx for Tovorafenib

NEW YORK – Roche subsidiary Foundation Medicine announced on Wednesday that it is collaborating with Day One Biopharmaceuticals to develop FoundationOne CDx as a companion diagnostic for Day One's tovorafenib.

The investigational drug is an oral, brain-penetrant, highly selective type II pan-RAF kinase inhibitor and is currently being evaluated in a Phase II clinical trial, FIREFLY-1, to treat relapsed pediatric low-grade glioma (pLGG) in pediatric, adolescent, and young adult patients, the companies said in a statement. Day One has also begun a Phase III study, FIREFLY-2/LOGGIC, for the drug in newly diagnosed patients with pLGG.

Tovorafenib is designed to target an enzyme in the MAPK signaling pathway and is also being studied alone or as a combination therapy for adolescent and adult patients with recurrent or progressive solid tumors with MAPK pathway aberrations.

FoundationOne CDx is used as a companion diagnostic for multiple drugs, but the companies noted that if tovorafenib and the assay are approved, this would be the first CDx indication for the test in pediatric oncology. The next-generation sequencing-based test detects substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements. It also detects genomic signatures, such as microsatellite instability and tumor mutational burden.

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