Thermo Fisher Scientific and Guardant Health announced on Friday that the U.S. Food and Drug Administration (FDA) has granted premarket approval for an assay as a companion diagnostic (CDx) to Enhertu.
Enhertu is an HER2-directed antibody drug conjugate being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The FDA had approved Enhertu on Thursday for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have HER2 (ERBB2) activating mutations as detected by an FDA-approved test, and who have previously received systemic therapy.
The agency granted premarket approval for Thermo Fisher Scientific's NGS-based Oncomine Dx Target Test as a CDx to identify patients whose tumors have HER2 (ERBB2) activating mutations (SNVs and exon 20 insertion) in non-small cell lung cancer and who may be candidates for Enhertu.
The Oncomine Dx Target Test, designed to simultaneously evaluate 23 genes associated with NSCLC, received its first FDA approval as a CDx in 2017.
Separately, Guardant Health said the agency has also approved its NGS-based Guardant360 CDx liquid biopsy test as a CDx to select patients with unresectable or metastatic HER2-mutant non-small cell lung cancer whose tumors have activating HER2 (ERBB2) mutations for treatment with Enhertu.
The Guardant360 CDx test provides comprehensive genomic results from a blood draw in seven days, helping clinicians and their patients move beyond the limitations of tissue biopsies, the firm said.