HYRNUO (sevabertinib)
First-line locally advanced or metastatic HER2-mutated non-squamous non-small cell lung cancer · Adults with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations and no prior systemic therapy
BAYRY · Bayer AG
Regulatory designations
Full timeline
3 milestonesFDA granted accelerated approval to HYRNUO as first-line therapy
FDA granted accelerated approval to HYRNUO for adults with locally advanced or metastatic non-squamous NSCLC with HER2 (ERBB2) tyrosine kinase domain activating mutations who had not received prior systemic therapy.
FDA — Accelerated approval of sevabertinib↗FDA granted Priority Review to the first-line sNDA
FDA granted Priority Review to the supplemental application supported by the ongoing Phase 1/2 SOHO-01 trial.
Bayer — HYRNUO sNDA Priority Review↗HYRNUO received its initial U.S. approval
FDA previously granted accelerated approval to HYRNUO for adults with HER2-mutated locally advanced or metastatic non-squamous NSCLC who had received prior systemic therapy.
FDA — Initial accelerated approval of sevabertinib↗Related News
No related news available.