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# Bayer Gets OK for Lung Cancer Drug
- URL: https://www.fdaweb.com/bayer-gets-ok-for-lung-cancer-drug/
- Published: 2026-09-09T12:00:00.000Z
- Updated: 2026-09-13T19:20:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161749

FDA has granted Bayer accelerated approval for Hyrnuo (sevabertinib), a kinase inhibitor for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-authorized test.

The expanded approval broadens the indication for sevabertinib, which was previously granted accelerated approval for adult patients with locally advanced or metastatic non-squamous NSCLC with HER2 TKD activating mutations who had received prior systemic therapy, according to the agency

Approval was based on data from SOHO-01 (NCT05099172), a 69-patient, single-arm, multicenter, multi-cohort clinical trial. The objective response rate was 75%, and 73% of responding patients had a duration of response (DOR) greater than six months and 38% saw a DOR of greater than 12 months, FDA says.

The approved labeling includes warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease/pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity, it adds.