Bayer Receives Breakthrough Therapy Designation in US and China for Sevabertinib in First-Line HER2-Mutant NSCLC

Bayer announced on January 6, 2026, that sevabertinib received Breakthrough Therapy Designation from the US FDA and China's Center for Drug Evaluation (CDE) for first-line treatment of patients with advanced HER2-mutant non-small cell lung cancer (NSCLC).123

The designations are supported by interim data from Cohort F of the phase 1/2 SOHO-01 trial (NCT05099172), showing a 59% overall response rate (ORR) and 84.6% disease control rate in treatment-naive patients.23

Sevabertinib is an oral, selective tyrosine kinase inhibitor targeting HER2 and EGFR mutations, particularly HER2 exon 20 insertions and point mutations.3

This follows prior FDA accelerated approval on November 19, 2025, for sevabertinib (Hyrnuo) in previously treated non-squamous NSCLC with HER2 tyrosine kinase domain mutations.45

A phase 3 SOHO-02 trial (NCT06452277) is ongoing, comparing sevabertinib to platinum-based chemotherapy plus pembrolizumab in the first-line setting.3

Sources:

1. https://firstwordpharma.com/story/7046767

2. https://www.investing.com/news/company-news/bayers-sevabertinib-receives-breakthrough-status-for-lung-cancer-treatment-93CH-4431537

3. https://www.targetedonc.com/view/fda-grants-breakthrough-status-to-sevabertinib-in-1l-her2-nsclc

4. https://www.ajmc.com/view/fda-approves-sevabertinib-for-nonsquamous-nsclc

5. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-sevabertinib-non-squamous-non-small-cell-lung-cancer