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Zongertinib Approved for HER2-Mutant Advanced Lung Cancer in the U.S.
8 Aug
Summary
- Zongertinib approved for HER2-mutant advanced NSCLC
- Demonstrated 75% objective response rate in clinical trial
- Represents significant advancement in lung cancer care
In a significant development for lung cancer care, the U.S. Food and Drug Administration (FDA) has approved Boehringer Ingelheim's zongertinib (HERNEXEOS) for the treatment of adult patients with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations.
The accelerated approval is based on data from the Phase Ib Beamion-LUNG 1 trial, which showed an impressive objective response rate of 75% among the 71 patients enrolled. Additionally, 6% of patients achieved a complete response, and 69% had a partial response, with a duration of response of at least 6 months in 58% of patients.
"With the approval of zongertinib, we have an effective, targeted, orally administered treatment option for patients with HER2 (ERBB2)-mutant non-small cell lung cancer in the U.S. that not only elicits a durable response but, importantly, has a manageable safety profile," said Dr. John Heymach, the coordinating investigator for the Beamion-LUNG 1 trial.
Zongertinib, a tyrosine kinase inhibitor that selectively targets HER2, represents a significant advancement in lung cancer care, particularly for a patient population with limited treatment options and a poor prognosis. The approval follows Priority Review and Breakthrough Therapy Designation granted by the FDA, underscoring the unmet need and the potential of this new therapy.
