MARCH 2026
FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option.
• HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as demonstrated in the Beamion LUNG-1 clinical trial1
• Accelerated approval follows Breakthrough Therapy Designation and prior FDA approval for previously treated patients in August 2025
Ingelheim, Germany and Ridgefield, Conn. February 26, 2026 -- The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.1
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 Boehringer is currently enrolling patients in Beamion LUNG-2, a confirmatory Phase III trial evaluating zongertinib as a first-line treatment for this patient population. (NCT06151574).
Accelerated approval is based on data from a cohort of treatment-naïve patients (N=72) in the Phase Ib Beamion LUNG-1 trial which demonstrated an objective response rate of 76%, including 11% of patients with a complete response and 65% of patients with a partial response.1Zongertinib demonstrated a duration of response of ≥6 months in 64% of patients.1 This data builds upon the FDA accelerated approval of HERNEXEOS for previously treated patients in August 2025.
FDA approves HERNEXEOS®, the first targeted therapy for adults with HER2-mutant advanced NSCLC as an initial treatment option.
• HERNEXEOS® (zongertinib tablets) approved based on an objective response rate of 76% (N=72) as demonstrated in the Beamion LUNG-1 clinical trial1
• Accelerated approval follows Breakthrough Therapy Designation and prior FDA approval for previously treated patients in August 2025
Ingelheim, Germany and Ridgefield, Conn. February 26, 2026 -- The U.S. Food and Drug Administration (FDA) approved Boehringer Ingelheim’s HERNEXEOS® (zongertinib tablets) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.1
This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1 Boehringer is currently enrolling patients in Beamion LUNG-2, a confirmatory Phase III trial evaluating zongertinib as a first-line treatment for this patient population. (NCT06151574).
Accelerated approval is based on data from a cohort of treatment-naïve patients (N=72) in the Phase Ib Beamion LUNG-1 trial which demonstrated an objective response rate of 76%, including 11% of patients with a complete response and 65% of patients with a partial response.1Zongertinib demonstrated a duration of response of ≥6 months in 64% of patients.1 This data builds upon the FDA accelerated approval of HERNEXEOS for previously treated patients in August 2025.
