FDA Gives Accelerated Approval to Sevabertinib in HER2+ NSCLC

FDA expands Bayer lung cancer drug approval

Today's biotech news includes UniQure readout testing durability of benefits, an AI effort to manage heart failure, and more

U.S. FDA Grants Accelerated Approval to Bayer’s HYRNUO® (sevabertinib) as a First-Line Targeted Therapy for Patients with HER2-Mutated Non-Small Cell Lung Cancer

WHIPPANY, N.J.--(BUSINESS WIRE)--Sep 9, 2026-

FDA Gives Accelerated Approval to Sevabertinib in HER2+ NSCLC

The FDA has granted accelerated approval to sevabertinib for metastatic non-squamous NSCLC with HER2 TKD activating mutations based on results from the SOHO-01 trial.