FDA Expands Approval of Hernexeos for First-Line HER2-Mutant Lung Cancer: 76% of Patients Saw Tumors Shrink

The FDA has approved zongertinib (Hernexeos) as the first treatment for adults with HER2-mutated non-small cell lung cancer, showing response rates that are over twice as high as the usual treatment. This approval was completed in just 44 days under the FDA's National Priority Voucher program.