Plans for Near-Term Resubmission of NDA for 1L Treatment Option for Unresectable HCC Following Type A FDA Meeting Reported
“The most critical outcome from our discussion with the FDA is that resubmission of Elevar’s NDA can occur without further remediation at the Hengrui manufacturing site,” commented Dr. Saeho Chong, Elevar chief executive officer. “Elevar left the meeting very motivated and with a clear path forward for resubmission, so patients and providers can soon have access to this novel combination therapy for uHCC where there continues to be a high unmet need. The resubmission will include the CARES-310 landmark analysis recently presented at ASCO, demonstrating the longest median overall survival (mOS) of 23.8 months for any treatment in a global Phase 3 trial for patients with uHCC.”
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