FDA Rejects Potential Kidney Cancer Rx

Tivozanib does not gain FDA approval for advanced renal cell carcinoma

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

(RxWiki News) The US Food and Drug Administration (FDA) has altered its rules for approving cancer medications. The agency used to judge medications based on the time during which the cancer didn’t get worse (progression-free survival).

Now the FDA is considering overall survival in its medication approval formula.

With this new approval strategy, the FDA has not approved tivozanib for the treatment of advanced kidney cancer.

While the medication extended progression-free survival, its overall survival was slightly less than a currently available medication.

The agency concluded the risks of the medication outweighed its benefits.

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The FDA issued what’s called a “Complete Response” letter which basically told Aveo, the developer of tivozanib, of its decision to reject the company’s New Drug Application (NDA).

Kidney cancer, technically known as renal cell carcinoma, will strike about 65,000 Americans, and nearly 14,000 individuals will succumb to the disease this year.

Tivozanib is an investigational drug that has been in clinical testing.

The FDA rejection does not leave kidney cancer patients without alternatives. Stutent (sunitinib) and Votrient (pazopanib) will remain the standard of care for advanced kidney cancer.

The agency made its recommendation against tivozanib primarily because of its side effects, with high blood pressure (hypertension) being the most serious.

The agency considers what's called the "hazard ratio," which is a numeric value of risks versus benefits.

The FDA does not approve any medication with a hazard ratio of more than 1. The hazard ratio for tivozanib was 1.25

However, This rejection is not the end of tivozanib. The medication is also being tested as a possible treatment for other cancers, including liver and colorectal.

Reviewed by: 
Review Date: 
June 10, 2013
Last Updated:
December 31, 2013