Boehringer Ingelheim has received the US Food and Drug Administration (FDA) accelerated approval for Hernexeos (zongertinib) to treat a type of lung cancer.
The drug is indicated for the treatment of patients with previously treated HER2-mutant advanced non-small cell lung cancer (NSCLC).
Hernexeos is a tyrosine kinase inhibitor that selectively targets HER2, offering a precision medicine approach to lung cancer therapy.
The drug targets HER2 mutations, which occur in nearly 2 to 4% of NSCLC cases and are linked to poor prognosis and brain metastases.
Comprehensive biomarker testing using next-generation sequencing identifies patients eligible for zongertinib treatment.
The FDA approval follows the FDA Priority Review, Breakthrough Therapy Designation and Fast Track Designations.
Continued approval may be contingent on verification of further clinical benefit in a confirmatory clinical trial.
Hernexeos is the first oral targeted therapy for HER2-mutant advanced NSCLC.
Boehringer Ingelheim board of managing directors’ chairman and human pharma head Shashank Deshpande said: “We are grateful to be able to bring forward Hernexeos, which has the potential to reset the benchmark for those living with HER2-mutant advanced non-small cell lung cancer, a condition associated with a particularly poor prognosis.
“Believing in the power of scientific innovation, we aim to provide meaningful improvements to this patient population.
“Recognising its potential, we accelerated development to deliver this new treatment option to patients within four years of starting the first clinical trial.”
The FDA approval of Hernexeos is based on the Phase Ib Beamion-LUNG 1 trial.
The study showed a 75% objective response rate among 71 patients, with 6% achieving a complete response and 69% a partial response.
Zongertinib showed a manageable safety profile with a 2.9% discontinuation rate.
Common adverse reactions included diarrhoea, hepatotoxicity, rash, fatigue, and nausea, affecting over 20% of patients.
Furthermore, Zongertinib is undergoing further evaluation in ongoing trials for various advanced solid tumours with HER2 alterations.
International Cancer Advocacy Network, President and CEO Marcia Horn said: “The advocacy community is thrilled about the approval of zongertinib, as it is another testament to the importance of personalised options for lung cancer that allow for a much more targeted approach for a subgroup of patients who have been waiting many years for innovative treatments.
“Understanding your cancer’s unique biomarkers, including HER2, through comprehensive testing is critical for all patients with NSCLC, as it can unlock targeted treatment options.”
