NDA Resubmitted to FDA for Camrelizumab + Rivoceranib for 1L Unresectable HCC Boosted by CARES-310 Leading OS Analysis
“Elevar’s timely resubmission of the NDA for the combination of camrelizumab and rivoceranib marks a critical milestone in our mission to bring a novel combination therapy for uHCC to patients and healthcare providers. HCC remains an area of significant unmet medical need,” said Dr. Saeho Chong, chief executive officer of Elevar Therapeutics. “This achievement would not have been realized without the extraordinary dedication of Elevar’s teams. We are eager to work with the FDA in the coming months as we focus on the commercialization of our combination therapy.” The resubmission is supported by the Phase 3 CARES-310 study landmark analysis presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, which reported median overall survival (mOS) of 23.8 months, the longest mOS for any treatment in a global Phase 3 trial for patients with uHCC, confirming the combination of camrelizumab and rivoceranib continued to show sustained long-term survival as a first-line treatment for uHCC.
Share:
More News
“Scripps has continued to be a valued partner of ours and we are pleased to extend our collaboration agreement to further explore the potential of our DNase-based oncology platform. We are grateful we are able to continue to leverage the knowledge and expertise of the team at Scripps to potentially
“The initiation of patient dosing in our Phase 2 trial of Ropidoxuridine for the treatment of patients with glioblastoma is a significant milestone for both Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies,” commented Shuttle Pharma’s Chairman and CEO, Anatoly Dritschilo, M.D. “The
“To our knowledge, Multikine is the only neoadjuvant immunotherapy that has shown overall survival benefit in the low and negative PD-L1 head and neck cancer population. This underscores the critical importance of having reached an agreement with the FDA on the method for identifying and selecting patients with low PD-L1
“We have decided to forgo future development of NKX019 in non-Hodgkin lymphoma. In reviewing the clinical data from the latest cohort of patients with large B-cell lymphoma and the evolving treatment landscape, Nkarta will focus its efforts on autoimmune diseases, where we believe NKX019 has potential to transform patient care.”,