Posted by Michael Wonder on 06 Jan 2026
Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer
6 January 2026 - Bayer receives breakthrough therapy designation in the US and China for sevabertinib as a first-line treatment for patients with HER2 mutant non-small cell lung cancer.
The breakthrough therapy designations are supported by preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 study evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic non-small cell lung cancer with HER2 activating mutations.
