FDA Approves FoundationOne CDx as Companion Diagnostic for BRAF Inhibitor Regimens in Melanoma


FoundationOne CDx has been approved by the FDA as a companion diagnostic for patients with melanoma undergoing treatment with a BRAF inhibitor.

The FDA has granted approval to FoundationOne CDx as a companion diagnostic for 2 groups of FDA approved regimens utilizing BRAF inhibitors, as well as for future FDA approved therapies for patients with melanoma, according to a press release from Foundation Medicine.1

Notably, FoundationOne CDx is currently the only FDA-approved companion diagnostic comprehensive genomic profile test that can be used across 2 groups of targeted therapies. Moreover, the regulatory decision may present an innovative and efficacious approach capable of simplifying the approval process for companies developing BRAF inhibitors without sacrificing quality standards.

“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,” Mia Levy, MD, PhD, chief medical officer at Foundation Medicine, said in a press release. “This approval will allow oncologists to uncover all possible FDA-approved treatment options for these indications through just 1 test, providing more insights for physicians and patients, more efficiently than ever before.”

In particular, the 2 regimens FoundationOne CDx is indicated for include encorafenib (Braftovi) and binimetinib (Mektovi), as well as dabrafenib (Tafinlar) and trametinib (Mekinist). The FDA approved the use of encorafenib and binimetinib for unresectable/metastatic BRAF-mutant melanoma in June 2018.2 The approval was based on findings from the phase 3 COLUMBUS trial (NCT01909453), which enrolled 577 patients with BRAF V600E– or V600K–mutation positive disease. Findings from the trial indicated that the combination yielded a median progression-free survival of 14.9 months vs 7.3 months among those treated with vemurafenib (Zelboraf) alone (HR, 0.54; 95% CI, 0.41-0.71; P <.0001).

Moreover, dabrafenib and trametinib received approval by the FDA in April 2018 as an adjuvant therapy for patients with BRAF V600E– or V600K–mutant melanoma.3 The combination was assessed as part of the phase 3 COMBI-AD trial (NCT01682083), which enrolled 970 patients with BRAF mutations and lymph node involvement. After 2.8 years of follow-up, investigators reported that the median relapse-free survival had not been reached in the experimental arm compared with 16.6 months in the placebo arm.

Any BRAF inhibitors approved by the FDA will also be included in the indication and FoundationOne CDx will automatically become available for use.


  1. 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://bit.ly/3rRfHy3
  2. FDA approves encorafenib and binimetinib in combination for unresectable or metastatic melanoma with BRAF mutations. News release. FDA. June 27, 2018. Accessed December 8, 2021. https://bit.ly/3EQXGDX
  3. Novartis receives FDA approval of Tafinlar® + Mekinist® for adjuvant treatment of BRAF V600-mutant melanoma. News release. Novartis. April 30, 2018. Accessed December 8, 2021. https://bit.ly/3rNaDKY
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