On 8 August, the US Food and Drug Administration (FDA) granted accelerated approval to Hernexeos (zongertinib) – a human epidermal growth factor receptor 2 (HER2) selective tyrosine kinase inhibitor – for adults with previously treated, unresectable, or metastatic non-small cell lung cancer (NSCLC) harbouring HER2 tyrosine kinase domain-activating mutations. Simultaneously, the FDA approved Thermo Fisher’s Oncomine Dx Target Test as the companion diagnostic (CDx) to identify patients eligible for Hernexeos. A CDx is an in vitro diagnostic test that plays a vital role in identifying patients who are suitable for a specific therapeutic intervention. It assesses biomarkers essential for the safe and effective use of corresponding drugs. Regulatory frameworks such as the FDA demand robust analytical and clinical validation linking biomarker presence to treatment response.
Thermo Fisher’s Oncomine Dx Target Test has been a pioneer in next-generation sequencing (NGS)-based CDx platforms, with the first approval for screening for multiple NSCLC therapies in 2017. The recent addition of HER2-tyrosine kinase domain (TKD) mutation detection further broadens the panel’s utility in targeted therapy selection. The decision was based on results from the Beamion LUNG-1 Phase Ib trial. In a cohort of 71 patients previously treated with platinum-based chemotherapy, the objective response rate was 75%, and 58% of these patients had a duration of response lasting at least six months. The Oncomine Dx Target Test is now validated to detect HER2-TKD-activating mutations in NSCLC and serves as a critical tool to identify patients who are candidates for zongertinib treatment. The CDx proves an essential part of the treatment.
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By evaluating multiple actionable biomarkers in a single test, NGS-based CDxs eliminate the delays of sequential assays, which is crucial in fast-progressing cancers such as NSCLC. Thermo Fisher’s ongoing partnerships with pharmaceutical companies streamline the co-development and simultaneous approval of drugs and their CDx, enhancing treatment rollout efficiency.
Thermo Fisher’s Oncomine Dx Target Test is not the only CDx on the market, but a vast majority of the approved CDxs are for oncology. A recent GlobalData report, Companion Diagnostics, shows that both pipeline and marketed CDx products have cancer as the top indication. Further, GlobalData expects the oncology diagnostics market to grow significantly, from $1.9bn in 2022 to over $3.1bn in 2030. CDxs are a crucial part of treatment for many patients. The ability to determine eligibility for targeted therapies, especially in oncology, can improve treatment significantly.
The simultaneous approvals of Hernexeos and the Oncomine Dx Target Test mark a significant advancement in the personalisation of lung cancer treatment. By pairing a highly targeted HER2-TKD therapy with an NGS-based CDx, healthcare professionals can more rapidly and accurately identify eligible patients, helping to deliver effective treatment.
As technologies such as the Oncomine platform continue to evolve, the integration of precision testing with innovative therapies promises to bring the benefits of precision medicine to more patients.
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