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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CEO Snehal Patel commented, “We are very encouraged to see that the preliminary results from FLAMINGO-01 show immune responses in both HLA-A*02 and non-HLA-A*02 patients. We are now considering the merits of adding a randomized placebo arm for non-HLA-A*02 patients, transforming this current open label third arm into effectively a
“At Ferring, we are committed to meeting the unmet needs in bladder cancer care and equipping uro-oncologists with critical evidence they need to deliver effective, and life-changing treatment,” said Joern Jakobsen, M.D., Ph.D., Vice President and Head of Global Research and Medical for Uro-Oncology and Urology, Ferring Pharmaceuticals. “These new
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“We do not view today’s unsatisfactory outcome as a failure of Globo H,” Dr. Heidi Wang, CEO of OBI Pharma added. “There may come a time, with a deeper scientific understanding of the Globo H function, it may play a meaningful role once again.”
