U.S. Food and Drug Administration Accepts New Drug Application for Zipalertinib for the Treatment of Locally Advanced or Metastatic Non‑Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
Zipalertinib has been accepted by the FDA as a new drug application for the treatment of locally advanced or metastatic non‑small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations.
FDA has accepted the NDA for zipalertinib, an oral EGFR tyrosine‑kinase inhibitor, based on Phase 2b REZILIENT1 data showing clinical benefit in NSCLC patients with EGFR exon 20 insertion mutations.
Zipalertinib offers a new treatment option for patients with limited options for NSCLC harboring EGFR exon 20 insertion mutations.
Evidence level: Klinikai vizsgálat. Formális klinikai vizsgálati eredmény.
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