FDA: Cancer Warnings Required for TNF Blockers

Here is the latest news from the FDA regarding TNF blockers and the risk of cancer:

FDA: Cancer Warnings Required for TNF Blockers

The U.S. Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases.

In addition, the FDA is working with manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

TNF blockers target and neutralize tumor necrosis factor-alpha (TNF-α), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. The drugs in this class include

• Remicade (infliximab),
  
• Enbrel (etancercept),
  
• Humira (adalimumab),
  
• Cimzia (certolizumab pegol) and
  
• Simponi (golimumab).

Today’s action is based on the completion of an investigation first announced by the FDA in June 2008. An analysis of U.S. reports of cancer in children and adolescents treated with TNF-blockers showed an increased risk of cancer, occurring after 30 months of treatment on average. About half of the cancers were lymphomas, a type of cancer involving cells of the immune system. Some of the reported cancers were fatal.

Additional required updates to the prescribing information include incorporation of reports of psoriasis associated with the use of TNF blockers.

Can you list who manufacturers the medications listed above? Eventually, I think we're going to realize that there's an increased risk of cancer with many of the biologic agents that are out there. The irony is that many biologic agents (different classes of drugs with varying mechanisms of actions) are also used to treat cancer. As we learn more about biologic agents, we may eventually complete the cancer circle. The more we understand about what causes cancer, the better we may be able to treat cancer.

Merck, Schering-Plough, and now J&J/Centocor

The Merck/Schering-Plough merger/reverse acquisition may hit some problems according to some because of J&J/Centocor and the co-marketing of Remicade (infliximab). Golimumab is a similar biologic agent that is currently in development. It is supposed to be co-marketed with Schering-Plough, but I guess we're not sure what's going to happen if Merck and Schering-Plough join forces. All these pharma merges/acquisitions are starting to get pretty crazy. Some are forecasting that thousands of jobs may get cut, but no one seems to be sure where those cuts may occur. I guess we'll just have to wait and see what happens here. These are some incredibly dramatic times in the pharma industry.