The FDA has granted an expanded accelerated approval to zongertinib (Hernexeos, Boehringer Ingelheim) for adults with unresectable or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain activating mutations. This February 2026 expansion builds on an earlier August 2025 approval for patients who had already received prior systemic therapy, now broadening eligible patient populations. HER2-mutant NSCLC represents roughly 2–4% of all NSCLC cases and has historically lacked dedicated targeted options. Zongertinib is a selective, irreversible HER2 inhibitor designed to minimize off-target toxicity. Also notable: the combination of avutometinib plus defactinib received accelerated approval in May 2025 for KRAS-mutated recurrent low-grade serous ovarian cancer, reflecting a broader trend of precision oncology targeting previously undruggable mutations.
