The U.S. Food and Drug Administration has granted premarket approval to Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients whose tumors have a HER2 (ERBB2) activating mutations (SNVs & Exon 20 Insertion) in non-small cell lung cancer (NSCLC) who may be candidates for ENHERTU(R) (fam-trastuzumab deruxtecan-nxki). ENHERTU is a specifically engineered HER2 directed antibody drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca. The FDA approved ENHERTU on August 11 for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 (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 U.S. FDA in April 2022. Lung cancer is the leading cause of cancer death among both men and women in the United States.(i) For patients with metastatic NSCLC, prognosis is particularly poor, as only 8% of patients will live beyond five years after diagnosis.(ii) HER2-mutant NSCLC occurs in approximately 2-4% of patients with non-squamous NCSLC,(iii) and Enhertu is the first HER2-directed therapy for patients with NSCLC approved in the U.S.