Camrelizumab + rivoceranib
A Chinese immunotherapy-plus-anti-angiogenic pill combination that clearly beat sorafenib in liver cancer, yet remains unapproved in the US after three manufacturing-related rejections.
CARES-310: median OS 23.8 vs 15.2 months (HR 0.62) and PFS 5.6 vs 3.7 months versus sorafenib in first-line unresectable HCC; approved in China (2023). FDA complete response letters in May 2024, March 2025 and July 2026, each on cGMP inspection deficiencies at the rivoceranib manufacturing site, not on clinical data. Rivoceranib (apatinib) is a selective VEGFR2 TKI; camrelizumab is a PD-1 antibody notable for reactive cutaneous capillary endothelial proliferation, which the TKI suppresses.
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- May 2024Complete response letterUS
First CRL: manufacturing inspection findings
- Mar 2025Complete response letterUS
Second CRL
- 30 Jan 2026Filing / dealUS
Resubmission accepted; PDUFA 23 July 2026 source
- 23 Jul 2026Complete response letterUS
Third CRL, again cGMP source
Approvals
| Region | Year | Indication |
|---|---|---|
| China | 2023 | First-line unresectable HCC |
Trials
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Camrelizumab + rivoceranib" OR ABSTRACT:"Camrelizumab + rivoceranib" OR TITLE:"SHR-1210 + apatinib" OR ABSTRACT:"SHR-1210 + apatinib") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Camrelizumab + rivoceranib, not a curated reading list.
Pages like this
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