Axitinib Granted Marketing Approval in Europe

Roxanne Nelson


September 04, 2012

September 4, 2012 — The European Commission has granted marketing authorization for axitinib (Inlyta, Pfizer) for the treatment of adult patients with advanced renal cell carcinoma. The indication is for patients who have failed prior treatment with sunitinib (Sutent, Pfizer) or a cytokine.

Axitinib was approved earlier this year by the US Food and Drug Administration (FDA) for the same indication — treatment of advanced renal cell carcinoma after the failure of 1 prior systemic therapy. It has also already been approved in several other countries including Switzerland, Japan, Canada, Australia, and Korea.

"Axitinib offers physicians and their patients with advanced kidney cancer a new treatment option following prior treatment with sunitinib or a cytokine," commented Bernard Escudier, MD, Head of the Immunotherapy Unit, Department of Medical Oncology, Institut Gustave Roussy, France. Dr Escudier served as an investigator on the Pfizer-sponsored study of axitinib and is a paid consultant to Pfizer Oncology.

The approval was based on data from the AXIS (A4061032) trial, a randomized, controlled, open-label, multicenter phase 3 trial that compared axitinib with sorafenib (Nexavar, Bayer HealthCare) as second-line systemic therapy. The cohort consisted of 723 patients with advanced renal cell carcinoma who had failed 1 previous therapy, and were randomly assigned to receive either axitinib 5 mg or sorafenib 400 mg, and the primary efficacy end point was progression-free survival. Sorafenib is a current second-line standard of care for this patient population.

Results showed that axitinib significantly extended progression-free survival, by 2 months more than sorafenib. The median progression-free survival was 6.8 months compared with 4.7 months for sorafenib, with a hazard ratio of 0.67 (0.56 - 0.81, P < .0001).

Dr. Escudier commented in a statement that the "data demonstrate statistically significant improvement in progression free survival compared with sorafenib, and support the continued role for VEGFR [vascular-endothelial-growth-factor-receptor]-targeted therapy, following the first-line standard of care."

Axitinib is an oral kinase inhibitor designed to selectively VEGF receptors 1, 2, and 3 at therapeutic plasma concentrations. These receptors have been implicated in pathologic angiogenesis, tumor growth, and cancer progression.

The adverse event profile for axitinib is similar to that of other drugs in the same class. The most common (≥ 20%) adverse reactions observed with axitinib include diarrhea, hypertension, fatigue, dysphonia, nausea, decreased appetite, and palmar-plantar erythrodysaesthesia (hand-foot) syndrome.

However, serious adverse reactions have been reported in patients receiving this agent, according to the manufacturer. These include arterial embolic and thrombotic events, venous embolic and thrombotic events, hemorrhage (including gastrointestinal hemorrhage, cerebral hemorrhage, and haemoptysis), gastrointestinal perforation and fistula formation, hypertensive crisis, and posterior reversible encephalopathy syndrome.

According to a statement issued by the FDA, patients with hypertension should have it well controlled before taking axitinib, and the drug is contraindicated in patients with untreated brain tumors or gastrointestinal bleeding.


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