The FDA handed out fast track and priority review designations across multiple oncology programs in July 2026, signaling continued regulatory momentum for new cancer mechanisms. The agency granted fast track status to SOTIO Biotech’s CDH17-targeting ADC SOT109 in advanced colorectal cancer, and to Oncolytics Biotech’s pelareorep immunotherapy in combination with atezolizumab for anal cancer. Separately, Pfizer’s talazoparib plus enzalutamide in HRR gene–altered metastatic castration-sensitive prostate cancer received priority review after TALAPRO-3 showed a 52% reduction in radiographic progression or death versus placebo plus enzalutamide. The designations were also described as reflecting unmet need and supporting data packages from ongoing clinical studies, including ORR, duration of response, and overall survival trends highlighted by companies.