Harpreet Singh: FDA Grants Accelerated Approval to Zongertinib for HER2-Mutant NSCLC
Harpreet Singh, Chief Medical Officer at Precision for Medicine, shared on LinkedIn:
“Last month, the FDA Division of Oncology 2 granted accelerated approval to Boehringer Ingelheim’s zongertinib (Hernexeos), an orally administered kinase inhibitor, for adults with unresectable or metastatic non-squamous NSCLC harboring HER2 (ERBB2) tyrosine kinase domain activating mutations, following prior systemic therapy. The agency also approved the Oncomine Dx Target Test as the companion diagnostic. Zongertinib was also approved in China earlier this week.
The decision was supported by the Beamion LUNG-1 trial, which showed strong response rates across patients previously treated with platinum-based chemotherapy, with and without HER2-targeted ADCs.
In this edition of CMO Confidential, I share the clinical context for HER2-mutant NSCLC, key safety considerations, and what to watch as confirmatory trials proceed.
Watch the full video for my perspective on this critical milestone.”
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