Successful FDA Type C Meeting conducted for IDE849 on Ph 3 Registrational Trial Design for Potential Accelerated and Full Approval in ES-SCLC
“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,” said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. “We also look forward to the clinical data updates at ESMO 2026 and later this year from our company sponsored clinical trial in ES-SCLC and NEC to support a potential best-in-class profile.”
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