Recent advances in cancer immunotherapy highlight both innovative approaches and regulatory hurdles. UCLA researchers engineered stem cells to continuously generate cancer-fighting T cells, representing a potential shift in immunotherapy. Concurrently, novel therapies such as Lepu Biopharma's T-cell engagers and chimeric exosomes improving triple-negative breast cancer immunotherapy have shown promise. However, regulatory challenges persist, as evidenced by the FDA's last-minute rejection of Replimmune’s melanoma drug RP1, sparked by intervention from the agency's top cancer regulator, Richard Pazdur. Industry insiders describe the FDA’s internal discord impacting approvals for cutting-edge cancer treatments, signaling continued tension between clinical innovation and regulatory governance.