[6] It was approved to treat renal cell carcinoma by the U.S. Food and Drug Administration after showing a modest increase in progression-free survival,[7] though there have been reports of fatal adverse effects.

[8] It has received approval for use as a treatment for renal cell carcinoma from the US Food and Drug Administration (FDA) (January 2012), the European Medicines Agency (EMA) (September 2012), the UK Medicines and Healthcare products Regulatory Agency (MHRA) (September 2012) and the Australian Therapeutic Goods Administration (TGA) (July 2012).

[1][9][10][11] A Phase II clinical trial showed good response in combination chemotherapy with gemcitabine for advanced pancreatic cancer.

[13] In 2010, a Phase III trial for previously treated metastatic renal cell carcinoma (mRCC) showed significantly extended progression-free survival when compared to sorafenib.

[14] In December 2011, the Oncologic Drugs Advisory Committee (ODAC) voted unanimously to recommend that US FDA approve axitinib for the second-line treatment of patients with advanced renal cell carcinoma (RCC), based on the results of the Phase III trial comparing axitinib and sorafenib.