FDA approval for first CGP test for melanoma therapeutics
pharmafile | December 9, 2021 | News story | Business Services |
The FDA has granted Foundation Medicine approval for its companion diagnostic, FoundationOne®CDx, for two groups of current and future FDA-approved therapeutics to treat melanoma. The CDx test is expected to support oncologists in selecting appropriate BRAF-mutation targeting therapy for their melanoma patients.
This approval includes monotherapies targeting BRAFV600E and BRAF/MEK inhibitor and combination therapies targeting BRAFV600E or V600K mutations. The FDA decision makes FoundationOneCDx the only comprehensive genomic profiling (CGP) test approved as a companion diagnostic across two groups of targeted therapies.
This approval represents a significant step toward simplifying decision-making for oncologists, providing an efficient regulatory approach simplifying the companion diagnostic approval process for biopharma companies developing BRAF inhibitor therapeutics.
BRAF mutations are changes in the DNA of some cancer cells that can be targeted with newer target therapies. BRAF mutations are usually acquired after birth in the process of a cell becoming a cancer cell.
Melanoma is a severe form of skin cancer, with BRAF as the most common type of mutations, found in more than half of all melanoma cases. The most common sign of melanoma is the appearance of a new mole or a change in an existing mole.
“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. “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.”
Ana Ovey
