Aug. 16, 2022—The FDA granted premarket approval to Thermo Fisher Scientific‘s Oncomine Dx Target test as a companion diagnostic to identify patients whose tumors have HER2 (ERBB2)-activating mutations (single nucleotide variants and exon 20 insertion) in non-small cell lung cancer who may be candidates for Enhertu (fam-trastuzumab deruxtecan-nxki). Enhertu is a specifically engineered HER2-directed antibody drug conjugate developed by Daiichi Sankyo and AstraZeneca.
The FDA approved Enhertu on Aug. 11 for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have ERBB2-activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. The approval follows a priority review, granted by the FDA in April.
“With care decisions increasingly made based on a tumor’s molecular profile, the FDA’s latest approval of Enhertu in HER2-mutant metastatic non-small cell lung cancer and the additional approval of the Oncomine Dx Target test as a companion diagnostic marks a significant step forward for precision oncology,” Garret Hampton, president, clinical next-generation sequencing and oncology at Thermo Fisher Scientific, said in a press release.
The Oncomine Dx Target test is available in 17 countries for 15 targeted therapies and designed to simultaneously evaluate 23 genes associated with NSCLC. The test received its first approval by the FDA as a companion diagnostic in 2017.