The drug that the companion diagnostic identifies patients for, zongertinib, received FDA approval for HER2-mutant NSCLC on August 8, 2025.
Approval Alert | Zongertinib in HER2+ Metastatic or Unresectable Nonsquamous NSCLC
Zongertinib is now approved by the FDA for patients with nonsquamous NSCLC with HER2 TKD activating mutations.
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