The New England Journal of Medicine recently published an article on combination therapy and how it is being developed to treat cancer. The article, entitled ‘Development of Novel Combination Therapies’, was written by Janet Woodcock, M.D., Joseph P. Griffin, J.D., and Rachel E. Behrman, M.D., M.P.H from the Food and Drug Administration (FDA).
The authors note how easy it is for illnesses like cancer to develop drug resistance when only one type of medication is used to treat them. They attribute this to the web-like structure of cellular pathways. When a drug obstructs one path, the illness becomes resistant and uses a different path. This is why combination therapies, using two or more types of medications or treatment, are necessary to treat many tumors effectively.
New drug development is usually conducted one therapy at a time, the article says, regardless of whether the disease being treated requires combination therapy. Sometimes additional new drugs are tested in add-on trials to see how supplementing a new drug compares with using the old drug alone. Concern has been expressed that the FDA policy of focusing on fixed-dose combinations, which means medications are contained in one tablet, inhibits the development of novel combination therapies.
The authors note that the FDA realizes its regulations are unethical for diseases likely to be treated with innovative targeted combination therapies. Their policies involve large-scale trials in which combination therapies are more likely to be rejected. Also, such trials could actually promote the development of resistance and make new therapies ineffective. The FDA is therefore committed to managing the risks in combination development programs and making such programs a primary FDA objective.
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