FDA Prioritizes Review of Bayer’s Sevabertinib for HER2-Mutant NSCLC

Bayer announced that the US Food and Drug Administration (FDA) has granted Priority Review to sevabertinib for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations.

FDA Priority Review reduces the standard review timeline from approximately 10 months to six months and is reserved for therapies that may offer significant improvements in treatment or address unmet medical needs.

The regulatory submission is supported by preliminary clinical data from cohort F of the ongoing Phase I/II SOHO-01 trial (NCT05099172), which is evaluating sevabertinib in treatment-naïve patients with HER2-mutant NSCLC. Bayer did not disclose detailed efficacy or safety findings from the cohort in the announcement.

Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division, said the FDA’s Priority Review decision reflects the company’s commitment to precision oncology and the need for improved therapies for patients with HER2-mutant NSCLC. He noted that current treatment options remain limited and emphasized the importance of developing more effective and better tolerated therapies that can be used earlier in the disease course.

Sevabertinib previously received FDA accelerated approval in November 2025 under the brand name Hyrnuo™ for patients with previously treated advanced HER2-mutant NSCLC. That approval was based on objective response rate (ORR) and duration of response (DOR) findings from cohorts D and E of the SOHO-01 study, which included patients previously untreated with HER2-targeted therapies as well as patients who had received HER2-directed antibody-drug conjugates (ADCs).

The therapy has also recently been approved in China by the National Medical Products Administration (NMPA) for adult patients with unresectable, locally advanced, or metastatic NSCLC with HER2-activating mutations who have received one prior systemic therapy. The therapy has also recently received MHRA approval in the UK for previously treated HER2-mutant advanced NSCLC, supported by durable clinical responses. Bayer did not provide details on potential regulatory submissions in Europe or Japan.

Sevabertinib originated from Bayer’s strategic research collaboration with the Broad Institute.

Beyond the SOHO-01 study, sevabertinib is also being evaluated in the Phase III SOHO-02 trial (NCT06452277) in treatment-naïve HER2-mutant NSCLC and in the panSOHO study (NCT06760819), which is investigating the therapy in metastatic or unresectable solid tumors with HER2-activating mutations outside of advanced NSCLC.

About Sevabertinib

Sevabertinib is an oral, reversible tyrosine kinase inhibitor (TKI) designed to selectively target HER2 mutations, including HER2 exon 20 insertions and point mutations, while also inhibiting EGFR. Bayer said its reversible mechanism may allow more controlled target inhibition with the potential for improved tolerability compared with irreversible TKIs.

HER2-Mutant NSCLC Remains a High-Unmet-Need Population

NSCLC accounts for more than 85% of lung cancer cases, while HER2-activating mutations occur in about 2% to 4% of advanced NSCLC patients. Despite the availability of HER2-directed therapies such as Enhertu, treatment resistance, disease progression, and safety challenges continue to drive the need for additional targeted therapies, particularly in earlier-line settings.

References

FDA grants sevabertinib Priority Review as a first-line treatment for patients with HER2-mutant non-small cell lung cancer

Study Details | NCT05099172 | First in Human Study of BAY2927088 in Participants Who Have Advanced Non-small Cell Lung Cancer (NSCLC) With Mutations in the Genes of Epidermal Growth Factor Receptor (EGFR) and/or Human Epidermal Growth Factor Receptor 2 (HER2) | ClinicalTrials.gov