FDA Approves First CGP Test as Companion Diagnostic for BRAF Inhibitor Therapies for Melanoma

The FDA approved FoundationOneCDx as the first companion diagnostic for current and future BRAF inhibitor therapeutics used to treat melanoma, including both monotherapies and combination therapies.

The FDA has granted Foundation Medicine approval for its companion diagnostic, FoundationOneCDx, for current and future BRAF inhibitor therapeutics used to treat melanoma, including monotherapies targeting BRAFV600E and BRAF/MEK inhibitor and combination therapies targeting BRAFV600E or V600K mutations.

The announcement marks the first time the FDA has approved a comprehensive genomic profiling (CGP) test as a companion diagnostic across 2 groups of targeted therapies, which represents an important step toward simplifying decision-making for oncologists.

Melanoma, a serious form of skin cancer, accounts for approximately 207,790 cases of cancer annually. BRAF mutations are the most common mutation type found in melanoma and are observed in more than half of all melanoma cases.

According to Foundation Medicine, as a companion diagnostic, FoundationOneCDx offers oncologists flexibility when choosing the most appropriate therapy for their patients with melanoma and helps to ensure that all treatment options are considered within groups of therapies that target BRAFV600E and BRAFV600K mutations.

“As the first group therapy approval for any comprehensive genomic profiling test, this milestone reinforces our dedication to pioneering advances that expand the power of genomic testing in cancer care,” said Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, in a statement.

The first therapies for which FoundationOneCDx is a companion diagnostic under the group approvals are Pfizer’s combination regimen of envorafenib (Braftovi) and binimetinib (Mektovi) and Novartis’ combination regimen of dabrafenib (Tafinlar) and trametinib (Mekinist). In the future, FoundationOneCDx will automatically become a companion diagnostic for future BRAF inhibitors that are approved by the FDA in these groups.

“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,” Levy commented.


FoundationOne®CDx receives FDA approval as a companion diagnostic for BRAF inhibitor therapeutics in melanoma. News release. Foundation Medicine. December 8, 2021. Accessed December 8, 2021. https://www.foundationmedicine.com/press-releases/0de60c95-8c71-49b7-b9b3-2d08466808f8