IDEAYA Bioscience Advances IDE849 Toward Phase 3 Trial Following FDA Meeting

IDEAYA Biosciences reported a successful FDA Type C meeting that finalized the design of its Phase 3 registrational trial for IDE849, a DLL3-targeting Topo-I antibody drug conjugate (ADC), in extensive-stage small cell lung cancer (ES-SCLC). The outcome de-risks the Phase 3 development plan by aligning key trial design elements with the FDA. This is a positive regulatory milestone that may support sentiment around the program’s path to potential approval.