On October 27, the U.S. Food and Drug Administration (FDA) approved the FoundationOne Liquid CDx test for three new companion diagnostic indications to help match patients who may benefit from treatment with specific FDA-approved targeted therapies. The new indications are for alpelisib (Piqray) in advanced or metastatic breast cancer; rucaparib (Rubraca) in advanced ovarian cancer; and alectinib (Alecensa) in ALK-positive metastatic non–small cell lung cancer (NSCLC). The FDA also approved a label expansion for FoundationOne Liquid CDx to report additional select copy number alterations and genomic rearrangements.
FoundationOne Liquid CDx analyzes the largest genomic region of any FDA-approved comprehensive liquid biopsy test and was approved in August 2020 to provide tumor mutation profiling in accordance with professional guidelines for patients with any solid tumor. Concurrently, it was approved as a companion diagnostic for a poly (ADP-ribose) polymerase (PARP) inhibitor approved by the FDA for the treatment of patients with metastatic castration-resistant prostate cancer with qualifying BRCA1 or BRCA2 alterations, and for three first-line EGFR tyrosine kinase inhibitors for the treatment of non–small cell lung cancer.
New Indications
The October 27 approval expands FoundationOne Liquid CDx’s companion diagnostic indications to include the following targeted therapies:
- Alpelisib, a kinase inhibitor indicated for use in combination with fulvestrant for the treatment of postmenopausal women, and men, with hormone receptor (HR)-positive, HER2-negative, PIK3CA-mutated, advanced or metastatic breast cancer following progression on or after an endocrine-based regimen. PIK3CA is the most commonly mutated gene in HR-positive/HER2-negative breast cancer; approximately 40% of patients with this subtype of breast cancer have the mutation.
- Rucaparib, a PARP inhibitor for the treatment of adult patients with a deleterious BRCA mutation (germline and/or somatic)-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies. An estimated one in four women with epithelial ovarian cancer have a mutation of the BRCA1 or BRCA2 gene.
- Alectinib, a tyrosine kinase inhibitor indicated for the treatment of patients with ALK-positive mutated NSCLC as detected by an FDA-approved test. ALK rearrangements are identified in approximately 5% of patients with NSCLC.
