Pfizer‘s new anti-cancer drug axitinib declared for new indications in China
On August 16, the official website of the Center For Drug Evaluation,NMPA announced that Pfizer‘s application for the listing of axitinib tablets for a new indication was accepted, with the specific indication yet to be disclosed.
Axitinib, an oral tyrosine kinase inhibitor (TKI) that blocks tumor angiogenesis by inhibiting the activity of vascular endothelial growth factor receptor (VEGFR) 1-3, was previously approved in China for the treatment of renal cell carcinoma.
Originally approved for marketing by the US FDA in 2012 and approved in China in 2015, the first indication is for the treatment of adult patients with progressive renal cell carcinoma (RCC) who have failed prior treatment with a tyrosine kinase inhibitor or cytokine.
In addition to targeting renal cell carcinoma, Pfizer has also completed an international multicenter (including China) Phase 3 clinical study evaluating the efficacy and safety of axitinib for the treatment of patients with advanced hepatocellular carcinoma who have failed a single prior anti-angiogenic therapy, according to the official website of the China Drug Clinical Trial Registration and Information Publication Platform.