FDA fast track and priority review designations in July 2026 spotlight continued acceleration for oncology drug candidates across multiple histologies. SOTIO Biotech’s CDH17-targeting ADC SOT109 received fast track for advanced colorectal cancer after exhaustion of standard treatment, supported by the company’s reported rationale around CDH17 expression. Oncolytics Biotech received fast track for pelareorep combined with atezolizumab for inoperable or metastatic anal cancer after prior systemic therapy, citing efficacy signals from the GOBLET study. Pfizer’s supplemental application for talazoparib plus enzalutamide in HRR-altered metastatic castration-sensitive prostate cancer received priority review. These designations can affect trial timelines and regulatory strategy, sharpening competition in ADCs, checkpoint combinations, and PARP/androgen-axis regimens.
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