FDA Expands Approval for Sevabertinib in Lung Cancer

The FDA has granted accelerated approval to sevabertinib, sold as Hyrnuo by Bayer Healthcare Pharmaceuticals, for adults with locally advanced or metastatic non squamous non small cell lung cancer whose tumors carry HER2 tyrosine kinase domain activating mutations, according to an FDA announcement. This expands an earlier accelerated approval that covered patients who had already tried other systemic therapies, so the drug can now be used as a first treatment option for this genetic subtype.

The decision rests on data from SOHO 01, an open label, single arm clinical trial. Among 69 previously untreated patients with the qualifying mutation, 75 percent had a confirmed objective response, and more than a third of responders maintained that response for at least a year. Because this is an accelerated approval, continued marketing depends on results from confirmatory trials showing a clinical benefit.

The prescribing information carries warnings for diarrhea, liver toxicity, lung inflammation, heart function changes, eye problems, pancreatic enzyme elevations, and risk to a developing fetus. The recommended dose is 20 mg taken orally twice daily with food until the disease progresses or side effects become unmanageable.

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