The U.S. Food and Drug Administration (FDA) has granted accelerated approval to Boehringer Ingelheim's oral drug zongertinib for the treatment of nonsquamous non-small cell lung cancer (NSCLC) with HER2 tyrosine kinase domain (TKD) mutations. The approval is based on clinical trial data demonstrating an objective response rate (ORR) of 75%, with 58% of patients experiencing responses lasting six months or longer. Zongertinib offers a more manageable side effect profile compared to traditional HER2-targeted antibody-drug conjugates. This approval marks a new treatment option for patients with advanced HER2-mutant NSCLC who have previously undergone treatment. Additional oncology developments include the FDA's approval of dordaviprone for diffuse midline glioma, priority review of liso-cel for marginal zone lymphoma, acceptance of a new PSMA PET imaging formulation, and progress of epcoritamab triplet therapy in follicular lymphoma. Furthermore, the FDA is conducting a priority review of a new drug application for the TAR-200 delivery system in bladder cancer, supported by phase 2b trial data showing a complete response rate of 82.4%, with over half of these responses lasting at least one year. In breast cancer research, the VERITAC-2 phase 3 trial highlights ESR1 mutations as a common cause of endocrine resistance, with new findings on the oral estrogen receptor degrader vepdegestrant recently summarized.