Posted by Michael Wonder on 01 Jul 2021
FoundationOne CDx receives FDA approval as a companion diagnostic for Alunbrig (brigatinib) to identify patients with ALK positive metastatic non-small cell lung cancer
1 July 2021 - Foundation Medicine today announced that it has received approval from the U.S. FDA for FoundationOne CDx to be used as a companion diagnostic for Alunbrig (brigatinib), which is currently FDA approved for the treatment of adult patients with anaplastic lymphoma kinase (ALK) positive metastatic non-small cell lung cancer as detected by an FDA approved test.
FoundationOne CDx, the only FDA approved tissue based comprehensive genomic profiling test, is now able to detect ALK positive metastatic non-small cell lung cancer and identify patients who may be appropriate for treatment with Alunbrig which is approved as a first-line or later-line therapy.
