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 the FDA Type C meeting, we are targeting to initiate a randomized Phase 3 registrational study for IDE849 monotherapy in extensive stage small cell lung cancer to enable a potential accelerated approval and full approval in one seamless study design.
The study aims to secure both accelerated and full FDA approval for IDE849 in extensive‑stage small cell lung cancer (ES‑SCLC) within a single seamless phase‑3 registrational trial.
Evidence level: Számítógépes vagy elméleti. Modellből vagy adatbányászatból származó jel.
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