Bayer announced that the US Food and Drug Administration (FDA) and China’s Centre for Drug Evaluation (CDE) had Breakthrough granted Therapy Designation to sevabertinib as a first-line treatment for patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) harbouring HER2-activating mutations.

Sevabertinib is an oral, reversible, small-molecule tyrosine kinase inhibitor (TKI) designed to selectively target HER2-activating mutations. The designation marked a significant regulatory milestone for Bayer’s oncology pipeline, highlighting the therapy’s potential in a cancer setting with limited treatment options and poor prognosis.

Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division, said, “The dual Breakthrough Therapy Designations from the US and China underscored sevabertinib’s potential to transform outcomes for patients with advanced HER2-mutant NSCLC. The decision followed closely on the FDA’s accelerated approval of sevabertinib for previously treated patients, reinforcing Bayer’s commitment to precision and personalised cancer care.”

The designations were supported by preliminary clinical evidence from cohort F of the ongoing Phase I/II SOHO-01 study, which evaluated the safety and efficacy of sevabertinib in treatment-naïve patients with locally advanced or metastatic HER2-mutant NSCLC.

Breakthrough Therapy Designation is intended to speed the development and review of medicines that may offer substantial improvement over existing therapies for serious or life-threatening diseases.

In November 2025, sevabertinib, marketed under the brand name Hyrnuo, had received FDA accelerated approval for patients with previously treated advanced HER2-mutant NSCLC. The approval was based on objective response rate and duration of response data from cohorts D and E of the SOHO-01 trial.

Sevabertinib potently inhibited mutant HER2, including exon 20 insertions and point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant versus wild-type EGFR. As a reversible TKI, it temporarily blocked its targets, potentially allowing for improved treatment control and reduced long-term side effects compared to irreversible inhibitors.

Lung cancer remains the leading cause of cancer-related deaths globally, with NSCLC accounting for more than 85 percent of cases. HER2-activating mutations occur in approximately 2 percent to 4 percent of advanced NSCLC patients, many of whom are diagnosed at late stages, underscoring the urgent need for more effective therapies.