FDA Grants Accelerated Approval to First Oral Targeted Therapy for HER2

The FDA has granted accelerated approval to Hernexeos ( zongertinib ), making it the first oral targeted therapy for previously treated adults with advanced lung cancer driven by HER2 mutations.

HER2 mutations occur in about 2% to 4% of non-small cell lung cancers (NSCLC) and are linked to a poor prognosis and a higher risk of brain metastases. Comprehensive biomarker testing, including next-generation sequencing, is recommended to determine whether a patient is eligible for HER2-targeted therapy.

“Until now, existing treatment options for HER2-mutant NSCLC consisted of chemotherapy with or without immunotherapy and HER2-directed antibody drug conjugates (ADCs), which require patients to travel to an infusion center or their provider’s office to receive the therapy every few weeks,”