FDA Grants Accelerated Approval to Sevabertinib for Non-Squamous NSCLC
The agency approved the kinase inhibitor for adult patients with locally advanced or metastatic disease.
Key takeaways
- On September 9, 2026, the FDA granted accelerated approval to sevabertinib (Hyrnuo).
- Sevabertinib is a kinase inhibitor developed by Bayer Healthcare Pharmaceuticals Inc.
- The drug is approved for adults with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
- Eligible patients must have tumors with HER2 (ERBB.
The Food and Drug Administration announced on September 9, 2026, that it has granted accelerated approval to sevabertinib, a kinase inhibitor. The therapeutic, marketed under the brand name Hyrnuo, is sponsored by Bayer Healthcare Pharmaceuticals Inc.
The FDA indicated that the approval is designated for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). To receive the treatment under this approval, patients must have tumors with HER2 (ERBB.
What Happened
On September 9, 2026, the FDA officially granted accelerated approval to the kinase inhibitor sevabertinib (Hyrnuo), sponsored by Bayer Healthcare Pharmaceuticals Inc. This regulatory decision designates the drug for adult patients with locally advanced or metastatic non-squamous NSCLC whose tumors have HER2 (ERBB.
What The Evidence Shows
The approval was announced by the FDA on September 9, 2026. The official regulatory publication did not report specific clinical trial results, response rates, or statistical safety and efficacy data.
What We Don't Know Yet
The source text does not report specific clinical trial data, patient sample sizes, study phases, efficacy rates, or the safety profile of sevabertinib. Additionally, the source text ends at 'HER2 (ERBB' and does not contain further information.
What Comes Next
The published source does not report planned confirmatory trials, future regulatory submission timelines, or next steps for the sponsor, Bayer Healthcare Pharmaceuticals Inc.
What This Means
Adult patients diagnosed with locally advanced or metastatic non-squamous NSCLC may now have access to sevabertinib if their tumors have HER2 (ERBB.
Original Source
FDA Drug and Biologic Updates: http://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-locally-advanced-or-metastatic-non-squamous-non-small
Questions readers ask
- What is the approved indication for sevabertinib?
- Sevabertinib is approved for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB.
- Who developed sevabertinib and what is its brand name?
- Sevabertinib is developed by Bayer Healthcare Pharmaceuticals Inc. and is marketed under the brand name Hyrnuo.
- What type of drug is sevabertinib?
- The FDA announced that sevabertinib is classified as a kinase inhibitor.
What this means
Adult patients diagnosed with locally advanced or metastatic non-squamous NSCLC may now have access to sevabertinib if their tumors have HER2 (ERBB.
Limitations and uncertainties
- The source text does not report specific clinical trial data, patient sample sizes, study phases, efficacy rates, or the safety profile of sevabertinib. Additionally, the source text ends at 'HER2 (ERBB' and does not contain further information.
Sources
- FDA grants accelerated approval to sevabertinib for locally advanced or metastatic non-squamous non-small cell lung cancer — FDA Drug and Biologic Updates
