CARLSBAD, Calif. — The U.S. Food and Drug Administration has approved Thermo Fisher Scientific’s Oncomine Dx Target Test as a companion diagnostic for HERNEXEOS (zongertinib tablets), a newly authorized targeted treatment for HER2 (ERBB2)-mutant non-small cell lung cancer (NSCLC).
The test, which uses next-generation sequencing (NGS), will help clinicians identify patients whose tumors carry HER2 tyrosine kinase domain activating mutations. The FDA approved HERNEXEOS on August 8 for adults with unresectable or metastatic non-squamous NSCLC who have received prior systemic therapy. It is the first oral targeted therapy available for this specific genetic mutation in NSCLC.
“This rare form of non-small cell lung cancer is linked to a poor prognosis and limited treatment options, making HERNEXEOS an important advancement in addressing the unmet needs of patients,” said Vicky Brown, senior vice president and head of immunology, oncology, and eye health at Boehringer Ingelheim. She said the collaboration with Thermo Fisher gives patients “another tool” to identify those eligible for the drug.
NSCLC accounts for up to 90 percent of lung cancer cases in the U.S., with HER2 mutations occurring in an estimated 2 to 4 percent of patients. The HERNEXEOS approval was granted under the FDA’s accelerated pathway, based on tumor response rates, with continued approval contingent on confirmatory trials.
Thermo Fisher’s Oncomine Dx Target Test was first cleared in 2017 and is now approved in 20 countries for multiple biomarkers and more than 20 targeted therapies. In the U.S., it is authorized for use in cancers including NSCLC, cholangiocarcinoma, astrocytoma, anaplastic thyroid cancer, medullary thyroid cancer, and thyroid cancer.
“The FDA’s approval of HERNEXEOS for previously treated patients living with HER2 (ERBB2)-mutant advanced non-small cell lung cancer signifies continued success in our efforts to develop timely and accessible companion diagnostics,” said Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher. She added that the milestone comes soon after the company launched a rapid NGS solution capable of delivering results in as little as 24 hours.
