Foundation Medicine Receives FDA Approval for its Tissue-Based Genomic Profiling Test

Foundation Medicine received approval from the U.S. Food and Drug Administration (FDA) for its FoundationOne CDx product, the company’s tissue-based genomic profiling test

FoundationOne CDx is to be used as a companion diagnostic for two groups of current and future FDA-approved therapeutics in melanoma, which includes BRAF inhibitor monotherapies targeting BRAFV600E and BRAF/MEK inhibitor combination therapies targeting BRAFV600E or V600K mutations.

FoundationOne CDx is a comprehensive genomic profiling (CGP) test approved as a companion diagnostic across two groups of targeted therapies, representing an important step toward simplifying decision making for oncologists.

Melanoma is a serious form of skin cancer that accounts for an estimated 207,790 cases each year.¹ BRAF mutations are the most common type of mutation in melanoma and are present in more than half of all melanoma cases.² As a companion diagnostic for therapies targeting BRAFV600E and BRAFV600K mutations in melanoma, FoundationOne CDx offers oncologists flexibility when selecting the right therapy for their melanoma patients.

“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,” says Mia Levy, MD, PhD, chief medical officer at Foundation Medicine. “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.”

The first new therapeutics for which FoundationOne CDx is a companion diagnostic under the group approvals are Pfizer’s BRAFTOVI/MEKTOVI and Novartis Tafinlar (dabrafenib) + Mekinist (trametinib) combination therapeutics. Moving forward FoundationOne CDx will automatically become a companion diagnostic for future BRAF inhibitors that are approved by the FDA under these groups.

References

¹ https://www.skincancer.org/skin-cancer-information/melanoma/
² https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3391993/