Oncomine Dx Target Test approved to identify patients eligible for HERNEXEOS (zongertinib tablets), the first and only orally administered targeted treatment for HER2 (ERBB2)-mutant NSCLC
Thermo Fisher Scientific has received approval from the US Food and Drug Administration (FDA) for its Oncomine Dx Target Test as a companion diagnostic (CDx) to identify patients who may be candidates for HERNEXEOS (zongertinib tablets), a tyrosine kinase inhibitor (TKI), developed by Boehringer Ingelheim. The test allows clinicians and pathologists to assess if non-small cell lung cancer (NSCLC) tumours harbor human epidermal growth factor receptor 2 (HER2/ERBB2) tyrosine kinase domain (TKD) activating mutations.
“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, Boehringer Ingelheim. “Through our collaboration with Thermo Fisher and leveraging the company’s proven track record with companion diagnostics, 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.”
The Oncomine Dx Target Test received its first approval by the FDA as an NGS CDx 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, covering more than 550 million lives globally. In the US alone, it is approved for targeted therapies in NSCLC, cholangiocarcinoma (CC), astrocytoma (AC) and oligodendroglioma (OG), anaplastic thyroid cancer (ATC), medullary thyroid cancer (MTC), and thyroid cancer (TC).
“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, Clinical Next-Generation Sequencing, Thermo Fisher Scientific. “We’re continuing to expand our solutions for our pharma partners, as this approval quickly follows the recent FDA approval of our latest rapid NGS solution that can deliver results in as little as 24 hours.”
