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FDA Medication Tracker

← All approvals · Cancer · 2025

Hyrnuo (sevabertinib)

The FDA approved Hyrnuo (sevabertinib) on November 19, 2025 to treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy.
Brand name
Hyrnuo
Generic name
sevabertinib
FDA approval date
November 19, 2025
Approved use (FDA wording)
To treat locally advanced or metastatic non-squamous non-small cell lung cancer with tumors that have activating HER2 tyrosine kinase domain activating mutations in patients who received a systemic therapy
Category on this site
Cancer

Official sources

Facts only. This site lists what the FDA has approved and what the FDA says each drug is approved for, quoted or closely paraphrased from FDA and openFDA records. It gives no medical advice, no dosing, and no comparisons, and it says nothing about whether a drug is right for anyone. Talk to a licensed clinician about any medication. Records can lag or contain errors; the FDA's own pages are authoritative.