New FDA clearance actions pushed several platform and investigational programs closer to human testing. The FDA cleared the University of Colorado Anschutz to run a CAR T-cell study in adults with advanced colorectal cancer and pediatric patients with solid cancers who have exhausted standard options. The move adds another academic CAR-T route into harder-to-treat solid tumor settings. Prelude Therapeutics also announced IND clearance for PRT-13722, an oral KAT6A selective degrader for HR+/HER2− breast cancer, extending the growing wave of targeted degraders into earlier clinical stages. Together, the updates highlight continued regulatory momentum for both cell therapies and protein-degradation approaches.
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