The test is approved to identify patients eligible for Hernexeos, an orally administered targeted treatment for HER2 (ERBB2)-mutant non-small cell lung cancer.
Thermo Fisher Scientific has received approval from the US Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic to identify patients who may be candidates for Hernexeos (zongertinib tablets), a tyrosine kinase inhibitor developed by Boehringer Ingelheim.
The test allows clinicians and pathologists to assess if non-small cell lung cancer (NSCLC) tumors harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain activating mutations.
The FDA approved Hernexeos on Aug 8 as the first and only orally administered targeted therapy for adult patients with unresectable or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received prior systemic therapy.
This indication was approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
“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,” says Vicky Brown, senior vice president and head of immunology, oncology, and eye health at Boehringer Ingelheim, in a release. “Through our collaboration with Thermo Fisher…we’re pleased that patients have another tool that can be used to identify those with HER2 (ERBB2) tyrosine kinase activating mutations in non-small cell lung cancer.”
Next-generation Sequencing Companion Diagnostic
The Oncomine Dx Target Test received its first approval by the FDA as a next-generation sequencing companion diagnostic in 2017, followed by regulatory approvals in 20 countries for 11 biomarkers and over 20 targeted therapies (availability of these approvals vary per region).
The test is reimbursed by government and commercial insurers in the US, Europe, Japan, South Korea, and Israel. In the US, it is approved for targeted therapies in NSCLC, cholangiocarcinoma, astrocytoma and oligodendroglioma, 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,” says Kathy Davy, president of clinical next-generation sequencing at Thermo Fisher Scientific, in a release. “We’re continuing to expand our solutions for our pharma partners, as this approval quickly follows the recent FDA approval of our latest rapid [next-generation sequencing] solution that can deliver results in as little as 24 hours.”
