The U.S. Food and Drug Administration (FDA) has approved Hyrnua (sevabertinib) for the treatment of adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain activating mutations.
NSCLC with HER2 mutation is a rare form of lung cancer. This subtype is most commonly found in female patients with no history of smoking.
Sevabertinib is an oral, reversible, tyrosine kinase inhibitor (TKI) that was granted Breakthrough Therapy designation in 2024. It has been approved for HER2-positive NSCLC based on objective response rate and duration of response from the ongoing phase 1/2 SOHO-01 clinical trial (NCT05099172).
The orphan drug was given accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval will require proof of clinical benefit in a confirmatory trial.
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