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Foundation Medicine Test Nabs FDA Approval as CDx for BRAF Inhibitor Therapeutics for Melanoma

NEW YORK – Roche's Foundation Medicine announced on Wednesday that the FoundationOne CDx test has been approved by the US Food and Drug Administration as a companion diagnostic for two groups of BRAF inhibitor therapies for melanoma.

The comprehensive genomic profiling, or CGP, test can be used as a CDx for current and future approved therapeutics in melanoma, including BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations. The test will automatically become a companion diagnostic for future BRAF inhibitors approved by the FDA that fall under the two groups, Foundation said.

The first therapeutics the assay is approved for are encorafenib/binimetinib (Pfizer's Braftovi/Mektovi) and dabrafenib/trametinib (Novartis' Tafinlar/Mekinist) combination therapeutics.

FoundationOne CDx is the only CGP test approved as a companion diagnostic across two groups of targeted therapies, Foundation said in a statement.

"This approval will allow oncologists to uncover all possible FDA-approved treatment options for these indications through just one test, providing more insights for physicians and patients more efficiently than ever before," Mia Levy, Foundation's chief medical officer, said in a statement.

The approval is the result of FDA guidance on therapeutic group labeling for companion diagnostics released in April 2020, which outlines how test developers can achieve broader companion diagnostic indications. The guidance is intended to ease patient access to precision oncology drugs, although test developers still must prove their companion tests can reliably predict response or non-response to a group of cancer drugs.