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# Bayer sNDA for Hyrnuo Granted Priority Review
- URL: https://www.fdaweb.com/bayer-snda-for-hyrnuo-granted-priority-review/
- Published: 2026-05-18T12:00:00.000Z
- Updated: 2026-09-14T13:39:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5161156

FDA has granted Bayer a priority review for its supplemental NDA for Hyrnuo (sevabertinib) as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. The filing seeks approval for sevabertinib in adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors carry HER2 tyrosine kinase domain activating mutations.

The submission is based on preliminary results from cohort F of the ongoing Phase 1-2 OHO-01 trial, which is evaluating the efficacy and safety of sevabertinib in previously untreated patients with advanced HER2-mutant NSCLC. “Patients with HER2-mutant NSCLC currently have limited treatment options, and there is an urgent need for more effective and better-tolerated therapies that can be used early in the disease course to help improve survival outcomes,” a Bayer release said.

Hyrnuo received an accelerated FDA approval in November for previously treated patients with advanced HER2-mutant NSCLC based on tumor response and duration-of-response data from the SOHO-01 study.

Lung cancer remains the leading cause of cancer-related deaths worldwide, with NSCLC accounting for more than 85% of cases. HER2 mutations occur in roughly 2% to 4% of advanced NSCLC patients, according to Bayer.