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Cancer Drugs: Weighing the Risks and Benefits
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Cancer Drugs: Weighing the Risks and Benefits

Cancer Facts:

• Cancer is the second most common cause of death in the United States, exceeded only by heart disease.
• Thirty years ago, 50 percent of the Americans diagnosed with cancer died from the disease within five years; today's five-year survival rate is 65 percent.
• The FDA has approved 43 new cancer drugs over the last 10 years, compared with 27 the previous 10 years.

Source: American Cancer Society, FDA

By Linda Bren

Few deliberations have greater bearing on human health than when the Food and Drug Administration weighs the risks and benefits of drugs designed to treat life-threatening diseases, such as cancer.

link to description of chartFDA physicians who specialize in treating cancer (oncologists), chemists, statisticians, microbiologists, pharmacologists, immunologists, and other experts work in 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.

How Are Cancer Drugs Reviewed?

Under federal law, 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 experts review cancer drug applications and evaluate study results. Sometimes, they seek outside advice, calling upon 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. The ODAC draws conclusions intended to guide the agency in its decision to approve or not approve the drug for marketing or for a new claim.

What Makes Cancer Clinical Trials Different?

link to description of chart on cancer drug approval ratesClinical 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.
What Do 'Safe' and 'Effective' Really Mean?

A cancer drug may be considered effective if it extends a person's life (survival), increases the probability that a person will remain alive without the disease getting worse (progression-free survival), shrinks the tumor (response rate), or relieves other symptoms. In short, FDA cancer drug reviewers ask, "Does the drug prolong life, control the disease, or relieve symptoms? And does the scientific evidence support it?"

These benefits are weighed against the risks of the drug. No drug is absolutely safe—all have some risks, or potential side effects. "Safe" means that the benefits of the drug outweigh the risks for its intended use in the population the drug is intended to treat.

Cancer drugs often contain potent ingredients that kill cancer cells. "Unfortunately, most of the drugs used to treat cancer aren't targeted," says Cortazar. "They kill the cancer cells, but at the same time, they kill healthy cells." The death of rapidly dividing healthy cells weakens the body's immune system, putting a person at risk for infections and other health problems.

Yet highly toxic effects may be considered acceptable if the benefits are important and the disease is very serious or life-threatening.  ...

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