Living with cancer blog

How new cancer drugs are developed

By Sheryl M. Ness, R.N. March 16, 2013

Have you ever wondered how new drugs are created and approved for the treatment of cancer?

Every year, researchers study and develop new treatments in hopes of finding just the right connection to stop or prevent the growth of cancer cells.

While it may seem that every day we hear about a new cancer treatment that's available, the tedious process can be 8-10 years in the making.

The agency regulating drug approval is the Food and Drug Administration (FDA) within the Department of Health and Human Services.

The FDA is in charge of making sure that new drugs, vaccines, gene therapies and other biological treatments are safe and effective before they are released on the market for standard treatment for cancer patients.

To make certain that new drugs are safe and effective, first the new drug is studied in the laboratory and with animals. Next, clinical trials with people are needed to study the safety and best dose of the new treatment. This is done in Phase I clinical trials.

After the first phase of study is complete, it moves on to Phase II to study how the new drug works against a specific cancer. Researchers continue to focus on safety and report the side effects, complications and short-term safety.

If the early phases of the research are promising, the drug continues on to Phase III which compares the new drug to standard treatment. This is typically done with hundreds of people across the country or around the world.

Finally, if the new drug proves to be better than the standard treatment, the FDA reviews all of the research data, including the risks and benefits and any new side effects, and makes a decision regarding approval.

During the process of approval, the FDA can decide if the new drug should have a priority classification — a faster approval, which means that the new treatment shows major benefits over existing treatment.

The FDA uses an independent advisory committee to review each new drug application. The committee is made up of experts in the field of medicine and research as well as consumers (patient advocates).

If you'd like to learn more about the approval process for new drugs, see the National Cancer Institute's website. For more information about cancer clinical trials, see Mayo Clinic's clinical trials website or the National Institute of Health's clinical trials website.

What are your thoughts on how new drugs are approved?


Sheryl M. Ness, R.N.

March 16, 2013