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Jump to Key Points The FDA has granted accelerated approval to sevabertinib (Hyrnuo, Bayer Healthcare Pharmaceuticals Inc.) for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain activating mutations, as detected by an FDA-authorized test.
The oral HER2 TKI was previously given accelerated approval in the second line for the indication and is the second one approved in the US for the indication, following the green light of zongertinib (Hernexeos, Boehringer Ingelheim Pharmaceuticals, Inc.) last year.
Approval was based on the open-label, single-arm SOHO trial in 69 previously untreated patients. The objective response rate was 75%; 73% of responders had a duration of response of 6 or more months, and 38% had a duration of response of 12 or more months.
The labeling includes warnings and precautions for diarrhea, hepatotoxicity, interstitial lung disease or pneumonitis, left ventricular dysfunction, ocular toxicity, pancreatic enzyme elevation, and embryo-fetal toxicity.
- FDA accelerated approval: sevabertinib for 1L locally advanced/metastatic non-squamous NSCLC with HER2 (ERBB2) activating mutations.
- Mutation must be detected by an FDA-authorized test.
- Oral HER2 TKI; second US approval for this indication, after zongertinib.
- SOHO trial (n=69 untreated): ORR 75%; 73% responders had DoR ≥6 mo.
- Key warnings: diarrhea, hepatotoxicity, ILD/pneumonitis, LV dysfunction, ocular toxicity, pancreatic enzyme elevation, embryo-fetal toxicity.
The recommended sevabertinib dose is 20 mg orally twice daily with food until disease progression or unacceptable toxicity.
M. Alexander Otto is a physician assistant and award-winning journalist. He is also an MIT science journalism fellow. Email: aotto@medscape.net
