IDEAYA Biosciences Announces Successful FDA Type C Meeting for IDE849, DLL3 TOP1 ADC, on Phase 3 Registrational Trial Design for Potential Accelerated and Full Approval in Extensive Stage Small Cell Lung Cancer
Based on FDA Type C meeting, targeting to initiate a randomized Phase 3 registrational trial for IDE849 monotherapy by year-end 2026 in ES-SCLC, with ORR by BICR as the primary endpoint for potential accelerated approval and median OS as the primary endpoint for potential full approval...
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