Innovent’s Cyramza (ramucirumab) Receives NMPA’s Approval for the Treatment of Hepatocellular Carcinoma
Shots:
- The NMPA has approved the sNDA for Cyramza to treat HCC who have an alpha-fetoprotein of ≥400ng/mL and have been treated with sorafenib. The therapy was discovered & developed by Lilly
- The approval was based on the P-III (REACH-2) study evaluating ramucirumab + BSC vs PBO + BSC in 403 patients with HCC. The results showed an improvement in OS; m-OS (8.5mos. vs 7.3mos.); m-PFS (2.8mos. vs 1.6mos.); ORR (4.6% vs 1.1%); DCR (59.9% vs 38.9%), was well-tolerated in Chinese patients & overall patient population. The safety & efficacy profile was consistent with prior reported global studies
- The therapy was approved in China in combination with paclitaxel for 2L treatment for advanced or metastatic, gastric, or GEJ adenocarcinoma
Ref: PRNewswire | Image: Innovent
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