Elevar Therapeutics Reports the US FDA Acceptance of NDA for Rivoceranib + Camrelizumab as 1L Treatment for Unresectable Hepatocellular Carcinoma
Shots:
- The US FDA has accepted an NDA for rivoceranib to treat patients with uHCC in combination with camrelizumab. The US FDA’s decision is expected on May 2024
- The NDA was based on the P-III study (CARES 310) results evaluating rivoceranib + camrelizumab vs sorafenib in 543 patients at 95 study sites across 13 countries/regions. The results showed a significant & clinically prolonged OS and PFS, m-OS (22.1 vs 15.2mos.), m-PFS (5.6 vs 3.7mos.) & confirmed ORR (25.4% vs 5.9%)
- The efficacy results were consistent across all subgroups. The combination therapy was approved in China as a 1L treatment for liver cancer while the company continues to advance rivoceranib as a monotx. for adenoid cystic carcinoma and as monotx. & combination therapies in other tumor cell types
Ref: Globenewswire | Image: Elevar Therapeutics
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