FDA Grants Accelerated Approval to Zongertinib (Hernexeos) for Non-Squamous NSCLC with HER2 TKD Mutations
The FDA accelerated approval of zongertinib (Hernexeos) brings a promising new option for advanced lung cancer patients with HER2 mutations.
The U.S. Food and Drug Administration has granted accelerated approval for zongertinib (Hernexeos) as a new targeted therapy for adults with unresectable or metastatic non‑squamous non‑small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. The expanded accelerated approval includes first‑line use as well as for patients whose cancers have progressed after prior systemic therapy.
Zongertinib provides a new therapeutic option that specifically targets HER2 mutations, which are rare but clinically significant in non‑squamous NSCLC, offering improved response rates and durability of response.
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