FDA Grants Accelerated Approval for New Lung Cancer Treatment

The U.S. FDA has granted accelerated approval to sevabertinib for the first-line treatment of HER2 TKD-mutant advanced non-squamous non-small cell lung cancer. This oral medication demonstrated a 75% objective response rate in the SOHO-01 study, with a significant portion of responders maintaining their response for at least six months, providing a new therapeutic option for patients with this specific cancer.