Pharmaceutical Business review

China approves Innovent sNDA for hepatocellular carcinoma treatment

Micrograph of hepatocellular carcinoma the most common form of primary liver cancer. Credit: Nephron / commons.wikimedia.org.

Discovered and developed by Lilly, Cyramza has been approved for the treatment of HCC patients with an alpha fetoprotein of ≥400 ng/mL and who have received treatment with sorafenib.

Cyramza is an antiangiogenic therapy that specifically binds to vascular endothelial growth factor receptor 2 (VEGFR-2) and blocks the receptor ligands’ (VEGF-A, VEGF-C, and VEGF-D) binding, which may slow the tumour growth.

The regulatory approval was based on the data obtained from the placebo-controlled, randomised, double-blind, global Phase III REACH-2 clinical trial.

In the study, the antiangiogenic therapy significantly improved the overall survival (OS) of patients compared to placebo.

It has also significantly improved the median progression-free survival (PFS) and was well-tolerated in Chinese patients as well as the overall patient population.

Innovent president Dr Yongjun Liu said: “Hepatocellular carcinoma ranks fifth among the number of new cases in China, with approximately 410,000 new cases yearly and the number of deaths each year are nearly the same.

“Most patients will experience disease progression after current first-line therapy and are left with limited treatment options.

“This differentiated product will potentially be an exciting treatment option and bring new hope to patients in China with advanced HCC.

“The successive approvals of Cyramza in second-line GC/GEJ and HCC this year enable us to provide integrated patient solutions with strong portfolio synergies while enhancing our leading franchise in these two large cancer indications.”

In March this year, the company and Eli Lilly and Company expanded their strategic partnership in oncology.