The FDA has granted accelerated approval to sevabertinib (brand name Hyrnuo), a new cancer drug from Bayer, for the treatment of a specific type of non-small cell lung cancer (NSCLC).

Hyrnuo is approved for adults with locally advanced or metastatic non-squamous NSCLC with specific HER2 (ERBB2) mutations, detected by an FDA-approved test, after prior systemic therapy. The drug is an oral tyrosine kinase inhibitor.

Accelerated approval was based on the SOHO-01 trial results showing an objective response rate of 71% in one patient group.

Continued approval relies on confirmatory trials. The Oncomine Dx Target Test was also approved as a companion diagnostic. The review involved international partners under "Project Orbis" and the drug had Breakthrough Therapy and Orphan Drug designations.

“The FDA’s approval of sevabertinib elevates the standard of care and provides a new treatment option for patients living with HER2-mutant NSCLC, which is a challenging disease with limited therapies available,” said SOHO-01 lead trialist, Xiuning Le, MD, PhD, The University of Texas MD Anderson Cancer Center, Houston, Texas. “Clinical results from the SOHO-01 trial showed that sevabertinib is effective with a manageable safety profile.”

 “Globally, it is estimated that up to 84,000 people are diagnosed with NSCLC harboring a HER2 mutation each year,” said Christian Rommel, Ph.D., Head of Research and Development at Bayer’s Pharmaceuticals Division. “At Bayer our oncology R&D strategy is centered on precision drug development which is designed to help us address critical unmet medical needs through the advancement of innovative therapies.”

In 2024, both the U.S. FDA and the CDE in China granted sevabertinib Breakthrough Therapy designation indicating that the compound has the potential to provide substantial improvement over existing therapies in NSCLC with HER2-activating mutations. China accepted a new drug application (NDA) for sevabertinib in July 2025. 

 Sevabertinib is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA.