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...microbiologists, pharmacologists, immunologists, and other experts work concert to evaluate cancer drug data, weigh the risks and benefits, and reach a decision to approve or not approve. If the scale is tipped on the side of benefits, the drug is approved and allowed on the U.S. market.
Patients, doctors, caregivers, and family members must also weigh the risks and benefits of drugs to decide which treatments to use.
Cancer is the second most common cause of death in the United States, according to the American Cancer Society, exceeded only by heart disease.
Thirty years ago, half of the Americans diagnosed with cancer died from the disease within five years. Today, the five-year survival rate is up to 65 percent, credited to advances in diagnosing cancers at an earlier stage and the development of more effective treatments.
The burgeoning research area of cancer drug development and an accelerated drug review process have produced many more treatment options. Over the last decade, the FDA has approved 43 new cancer drugs, compared with 27 during the previous decade.
Cancer Drug Review Process
Cancer drugs are regulated by the FDA under the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act. Under the acts, the FDA may approve a new drug for marketing in the United States if it is supported by substantial evidence of safety and effectiveness demonstrated in adequate and well-controlled studies.
The drug's manufacturer or marketer must show this evidence by submitting an application to the FDA that includes results from studies of the drug's use in people (clinical trials).
FDA oncologists and other agency experts review cancer drug applications and evaluate the study results. When seeking outside advice regarding drug approval or drug labeling, the FDA calls upon the expertise of a group of leading cancer specialists, clinical practitioners, and patient representatives who make up the FDA's Oncologic Drugs Advisory Committee (ODAC).
At an ODAC meeting, the pharmaceutical company presents findings from clinical trials on safety and effectiveness of the drug, and FDA staff present their assessments after reviewing the drug application, which includes extensive documentation about the drug's chemistry, its proposed use for one or more specific purposes, and data from clinical trials. The ODAC carefully considers the presentations and votes on questions posed by the FDA intended to guide the agency in its decision to approve or not approve the drug for marketing or for a new claim.
Cancer Clinical Trials
Clinical trials for cancer drugs are somewhat different from those for drugs used to treat illnesses that are less serious. For a less severe disease or condition, the commercial sponsor may show that the drug works better than an inactive substance (placebo), but generally does not have to show that it works as well or better than other drugs on the market to treat the same illness.
Studies involving cancer drugs usually do not use placebos, says Patricia Cortazar, M.D., an oncologist in the FDA's Office of Oncology Drug Products. "Because cancer is a life-threatening illness, it would not be ethical to give placebo when something better than placebo is available." In cancer trials, a new drug is usually compared to a drug or a combination of drugs that are commonly accepted and widely used to treat the same type of cancer, known as the standard of care, or standard treatment.
"The standard of care changes over time as new drugs or drug combinations that are shown to be better become available," says Cortazar.
The FDA may approve a drug for several uses (indications). If a drug is approved for one indication, it must still be shown in clinical trials to be safe and effective before the FDA will approve it for another indication.
For example, the drug Erbitux (cetuximab) was approved in 2004 to treat colon or rectal (colorectal) cancer that had spread to other parts of the body (metastasized). In 2006, Erbitux was approved to treat patients with head and neck cancer whose cancer is...
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