FDA approval delayed and retry…what’s 'Rivoceranib'?

By Son, Hyung-Min | translator Kang, Shin-Kook

24.05.21 05:55:54

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Acquired rivoceranib from Bukwang Pharm in 2018…effective in treatments for liver cancer and stomach cancer

It has shown significant improvements in survival period…"Due to Jiangsu Hengrui Pharmaceuticals’ monitoring issue...we will cooperate and retry to get approval"

HLB’s rivoceranib, which was expected to be an FDA-approved new drug candidate, failed to receive final approval.

Although HLB confirmed that Rivoceranib combined with immunotherapy camrelizumab extended overall survival in the first-line treatment for liver cancer, they received request for supplementary documents. The current request for supplementation is not related to the drug’s effectiveness but rather to an issue concerning the monitoring of Jiangsu Hengrui Pharmaceuticals’ Chemistry, Manufacturing and Controls (CMC) process. Therefore, HLB plans to cooperate and reapply for approval soon.

HLB announced on the 17th that they received a complete response letter (CRL) request fro

Son, Hyung-Min(shm@dailypharm.com)

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