Cancer drug development process
- Once a new drug has been identified, it is first tested in a laboratory to learn how it is used by the body, identify potential side effects, and figure out what doses are safe to use.
- If the results of laboratory testing suggest the drug is likely to be safe and effective, it will be evaluated in research studies involving volunteers, known as clinical trials.
- Once clinical testing is complete, the U.S. Food and Drug Administration (FDA) will review the results and may approve the drug if the evidence shows it is safe and effective. Then the drug can be made available to doctors and patients.
Doctors and scientists are always looking for better ways to treat people with cancer. To do this, they are constantly developing and studying new drugs, as well as looking for new ways to use existing drugs.
For a drug to go from being an idea in the laboratory to something that can be prescribed by a doctor, it must go through an extensive development and approval process to make sure it effectively treats cancer and is safe for people to take. Typically, this process takes many years and costs hundreds of millions of dollars. However, depending on the drug, the actual amount of time and money required varies.
Preclinical research: Drug discovery and initial testing
The discovery of new cancer drugs happens in a variety of ways.
Accidental discovery. In the early 1940s, an explosion exposed sailors to poisonous mustard gas. After observing that these sailors developed low white blood cell counts, doctors began using nitrogen mustard (mechlorethamine [Mustargen]) to treat Hodgkin lymphoma, a cancer of the lymphatic system involving the white blood cells. Mechlorethamine is still used as a cancer treatment today. Accidental discoveries such as this are rare, though.
Testing plants, fungi, and animals. Paclitaxel (Taxol), which is used to treat several types of cancer, was originally identified in the bark of the Pacific Yew tree. More recently, the drug eribulin (Halaven) was developed from a primitive animal called a sea sponge. The National Cancer Institute (NCI) has samples of thousands of plants, marine organisms, bacteria, and fungi collected from around the world in the hopes of discovering new cancer treatments.
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