The FDA granted accelerated approval to Bayer’s oral HER2‑targeted therapy for advanced non‑small cell lung cancer with specific HER2 mutations, moving to preserve competitiveness after a recent Boehringer Ingelheim approval. The agency’s action provides Bayer an early commercial foothold in a mutation‑defined lung oncology niche. The approval hinges on response and biomarker data that showed activity in a molecularly selected population. Clinicians and payers will evaluate how the new oral option compares on efficacy, safety and convenience to existing HER2‑targeting agents and whether label specifics limit patient eligibility. The decision underscores the regulatory appetite for targeted therapies in rare genomic subgroups and sharpens competition among oral small molecules and emerging targeted regimens for HER2‑mutant lung cancer.