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NewsElevar Therapeutics has resubmitted its FDA application for camrelizumab plus rivoceranib as a first-line treatment for unresectable or metastatic liver cancer — the fourth submission overall. The latest rejection in July 2026 was due to manufacturing issues, not safety or efficacy concerns. The combo showed a significant survival advantage over sorafenib in the phase 3 CARES-310 trial.
Elevar Therapeutics filed its fourth NDA submission to the FDA on October 9, 2026, seeking approval of camrelizumab (a PD-1 inhibitor) plus rivoceranib (a VEGFR-targeting TKI) for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC). The resubmission comes after a third complete response letter (CRL) issued in July 2026 — which, like prior rejections, cited manufacturing deficiencies at the Hengrui Pharma facility rather than any concerns about the drug's safety or effectiveness.
The application is backed by the global phase 3 CARES-310 trial, which enrolled 543 patients and compared the combination against sorafenib, the current standard of care. The combo delivered a meaningful survival benefit, and results were consistent across patient subgroups.
By the Numbers:
Why it matters: Despite strong clinical data, this combination has been stuck in regulatory limbo for over two years due to manufacturing hurdles — not science. If approved, it could offer a new frontline option for HCC patients, a population with historically limited treatment choices.