FDA grants accelerated approval to zongertinib for non-squamous NSCLC with HER2 TKD activating mutations

FDA

8 August 2025 - Today, the FDA granted accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals), a kinase inhibitor, for adults with unresectable or metastatic non-squamous non-small cell lung cancer whose tumours have HER2 tyrosine kinase domain activating mutations, as detected by an FDA approved test, and who have received prior systemic therapy.

FDA also approved the Oncomine Dx Target Test (Life Technologies Corporation) as a companion diagnostic device to aid in detecting HER2 tyrosine kinase domain activating mutations in patients with non-squamous non-small cell lung cancer who may be eligible for treatment with zongertinib.

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Michael Wonder

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Michael Wonder

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Cancer , Outcome , Medicine , US