Innovent Biologics Inc. (HKG: 1801) has announced that the supplementary Biologic License Application (sBLA) for its anti-tumor drug Cyramza (ramucirumab) in hepatocellular carcinoma (HCC) has been approved by the National Medical Products Administration (NMPA). The indication focuses on patients with alpha fetoprotein (AFP) ≥ 400 ng/mL who have previously been treated with sorafenib. This approval marks a significant expansion of Cyramza’s therapeutic applications in China.
Previous Approvals and Market Presence
Cyramza was previously approved for marketing in China in March 2022 to treat second-line advanced metastatic gastric cancer in combination with paclitaxel. The drug’s originator, Eli Lilly, granted Innovent the rights to import, sell, promote, and distribute the drug in China.
Approval Based on REACH-2 Study
The latest approval is based on the randomized, double-blind, placebo-controlled Phase III REACH-2 study, the first study in a biomarker-concentrated population with positive results in the liver cancer field. The main cohort results showed that Cyramza significantly prolonged the median overall survival (OS: 8.5 months vs 7.3 months) and median progression-free survival (PFS: 2.8 months vs 1.6 months) compared with a placebo. Additionally, Cyramza significantly improved the objective response rate (ORR: 4.6% vs 1.1%) and disease control rate (DCR: 59.9% vs 38.9%), and was well tolerated.
Future Outlook
The approval of Cyramza for hepatocellular carcinoma underscores Innovent Biologics’ commitment to advancing innovative treatments for liver cancer. By expanding its indications, Innovent aims to improve patient outcomes and address significant unmet medical needs in oncology.-Fineline Info & Tech
