Elevar Therapeutics and China-based partner, Jiangsu Hengrui Pharmaceuticals, received a third complete response letter (CRL) from the U.S. FDA regarding their combination treatment of rivoceranib and camrelizumab for hepatocellular carcinoma (HCC), the most common type of liver cancer.
Elevar says the FDA raised no new concerns about efficacy or safety and didn't ask for additional trials. Instead, the letter traces back to a cGMP inspection at a Hengrui manufacturing site listed on the rivoceranib application which had drawn a Form 483 following an April 2026 FDA visit. The FDA told Elevar the application can't move forward until the site's cGMP compliance is verified, and it's reserving the right to run a pre-approval inspection on top of that before signing off.
The first CRL, issued in May 2024, was related to GMP deficiencies at a Hengrui facility (that time the one making camrelizumab) plus incomplete Bioresearch Monitoring (BIMO) inspections. Elevar resubmitted in September 2024, banking on CARES-310 survival data (a 23.8-month median overall survival, the longest reported for a first-line HCC regimen), and the FDA set a March 2025 PDUFA date, only to issue a second CRL. The second CRL cited both findings from a CMC inspection and the FDA's inability, due to travel restrictions, to complete inspections of key clinical trial sites, primarily in Russia and Ukraine.
Now, Elevar is reviewing the CRL and says it will work closely with the FDA to determine the appropriate path forward. “Importantly, we continue to believe in the strength of the clinical data supporting this combination and remain committed to pursuing opportunities that may bring this treatment option to patients in need,” said Dong-Gun Kim, Elevar CEO.