Kidney Cancer Rx Approved in Europe

Inlyta receives EU marketing authorization to treat advanced renal cell carcinoma

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Kidney cancer doesn’t usually have any warning signs until it has become pretty serious. In fact, about a third of patients are diagnosed with an advanced stage of the disease. A medication has been approved in Europe to treat kidney cancer that has spread.

The European Commission (EC) has approved Inlyta (axitinib) to treat adult patients with advanced renal cell carcinoma (RCC), a type of kidney cancer, after other therapies have failed.

The medication has been granted marketing authorization to treat advanced kidney cancer after Sutent (sunitinib) or a cytokine – a chemotherapy drug – haven’t worked.

"Ask how you’ll know if a medication stops working."

Inlyta is in a class of drugs called kinase inhibitors. Taken by mouth, the pill blocks cell proteins that are involved in tumor growth and spread. ,

“Inlyta data demonstrate statistically significant improvement in progression free survival compared with sorafenib, and support the continued role for VEGFR-targeted therapy, following the first-line standard of care, Sutent," said Dr. Bernard Escudier, head of the immunotherapy unit at Institut Gustave in Roussy, France.

Dr. Escudier served as an investigator on the Pfizer-sponsored study that led to this approval. He is also a paid consultant to Pfizer Oncology.

The approval is based on a trial that found Inlyta extends the time before the cancer gets worse. This is called progression free survival or PFS for short.

The phase III trial found that those treated with Inlyta had PFS of 6.8 months compared to 4.7 months among those treated with Sutent.

Sutent is the standard of care first-line therapy used to treat renal cell carcinoma. Nexavar (sorafenib) is also used to treat this cancer.

About 102,000 people in Europe are diagnosed with renal cell carcinoma every year. In the U.S., some 65,000 people learn they have kidney cancer each year.

The U.S. Food and Drug Administration approved Inlyta in January, 2012 for treatment of RCC after one systemic therapy failed.

This medication has also been approved in a number of other countries, including Switzerland, Japan, Canada, Australia and Korea, according to Pfizer, Inc., which makes Inlyta.

Reviewed by: 
Review Date: 
September 4, 2012
Last Updated:
September 5, 2012