The U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to several novel cancer treatments in August 2025. Izalontamab Brengitecan, an EGFRxHER3 antibody-drug conjugate developed by Bristol-Myers Squibb (BMY), received the designation for patients with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC). Additionally, durvalumab was granted both priority review and breakthrough therapy designation for resectable, early-stage, locally advanced gastric and gastroesophageal junction cancers. Jemperli (dostarlimab) also received breakthrough therapy status for locally advanced dMMR/MSI-H rectal cancer. Other notable developments include the HER2-targeted ADC BB-1701 demonstrating efficacy and manageable safety in a phase 2 study for patients with locally advanced or metastatic HER2-positive or HER2-low breast cancer previously treated with HER2-directed ADCs. The combination of onvansertib with standard-of-care bevacizumab plus chemotherapy showed early efficacy signals in previously untreated, RAS-mutated metastatic colorectal cancer. Furthermore, the FDA approved datopotamab deruxtecan as a new therapeutic option for hormone receptor-positive, HER2-negative metastatic breast cancer, highlighting its differentiated safety profile compared to other ADCs. These advancements reflect ongoing efforts to improve treatment outcomes across various cancer types. Meanwhile, evolving FDA guidance on lung cancer therapies is influencing benchmarks for objective response rate, progression-free survival, and overall survival in drug evaluation.