FDA’s Breakthrough Designation Marks a Milestone for HERNEXEOS® in Lung Cancer Care
Boehringer Ingelheim has announced that HERNEXEOS® (zongertinib tablets) has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for the first-line treatment of adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain activating mutations.
The Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious conditions, particularly when early clinical evidence indicates the treatment may offer significant improvements over existing therapies.
HERNEXEOS was recently approved in the U.S. for adult patients with unresectable or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain mutations who have previously received systemic therapy.
This approval was granted under the FDA’s accelerated approval pathway, based on surrogate endpoints such as objective response rate (ORR) and duration of response (DoR). Continued approval may be contingent upon verification and description of clinical benefit in confirmatory clinical trials.
