The US Food and Drug Administration (FDA) has granted priority review to Boehringer Ingelheim’s new drug application (NDA) for zongertinib to treat unresectable or metastatic non-small cell lung cancer (NSCLC).
The decision is intended for individuals who have undergone a previous systemic therapy and have tumours with human epidermal growth factor receptor 2 (HER2) (ERBB2) mutations.
Go deeper with GlobalData
A Prescription Drug User Fee Act (PDUFA) action date was set by the agency for the third quarter of 2025.
Boehringer Ingelheim Human Pharma head and member of the board of managing directors Shashank Deshpande stated: “We believe zongertinib has the potential to transform the care of previously treated patients with HER2 (ERBB2)-mutant advanced non-small cell lung cancer and are hopeful about the continued research in other tumour types and lines of therapy.
“Priority review illustrates the urgent need in this patient population and the possibility for zongertinib to be a groundbreaking innovation for patients with limited treatment options.”
The NDA was based on the positive outcomes from the Phase Ib Beamion LUNG-1 trial.
Cohort 1 comprised 75 subjects with mutations in the HER2 tyrosine kinase domain. The data from this cohort showed a 71% objective response rate, a six-month progression-free survival rate of 69% and a duration of response rate of 73%.
The safety profile of the therapy was determined with only 5% of subjects requiring dose reductions and 3% discontinuing treatment due to adverse effects.
The FDA had previously granted breakthrough therapy and fast-track status and Japan’s Pharmaceuticals and Medical Devices Agency had awarded orphan drug designation.
An irreversible tyrosine kinase inhibitor, zongertinib selectively targets HER2 mutations while sparing epidermal growth factor receptor, minimising toxicity.
Administered orally, it is being developed not only for HER2-mutant advanced NSCLC and evaluated in studies for other solid tumours with HER2 alterations.
Boehringer Ingelheim opened a €60m ($66.8m) research building in Vienna, Austria, in September 2024, signalling the company’s intention to expand its presence in the oncology sector.
