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FDA approves FoundationOneCDx as companion diagnostic for melanoma.- Foundation Medicine

Read time: 1 mins

Published:9th Dec 2021

Foundation Medicine announced that it has received approval from the FDA for FoundationOneCDx 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.

This approval makes FoundationOneCDx the only 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.

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

Condition: Solid Tumours

Type: drug

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