FDA granted fast track designation to multiple oncology programs in July, signaling heightened review priority across colorectal cancer, anal cancer, and malignant pleural mesothelioma, among other areas. Separate agency actions included priority review acceptance for a talazoparib and enzalutamide combination in metastatic castration-sensitive prostate cancer. In colorectal cancer, SOTIO’s CDH17-targeting antibody-drug conjugate SOT109 entered fast track after the company highlighted unmet need after standard therapy. In anal cancer, Oncolytics’ pelareorep plus Tecentriq gained fast track status based on GOBLET study efficacy metrics. For prostate cancer, Pfizer’s supplemental application for talazoparib plus enzalutamide is backed by Phase 3 TALAPRO-3 findings showing a 52% reduction in radiographic progression or death versus placebo plus enzalutamide. Collectively, the designations tighten timelines for regulatory decisions on pivotal oncology readouts.