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‘Accelerated’ FDA Approval Still Too Slow

The Food and Drug Administration isn't doing enough to help speed potentially lifesaving cancer drugs from the lab to patients, a new study says.

Cancer therapies in the FDA's "accelerated approval" program - created in 1992 to help patients with life-threatening diseases such as AIDS - get to market no more quickly than other drugs, says a study funded by the National Cancer Institute published online today in the Journal of Clinical Oncology.

New cancer drugs took about seven years to get approved, whether they were part of the accelerated process or not, researchers found. Nineteen new cancer drugs have gotten accelerated approval since 1995, along with 32 given regular approval, the study says.

"This is a disappointment," says main author Charles Bennett, a professor at Chicago's Northwestern University Feinberg School of Medicine.

The accelerated approval program is supposed to allow promising drugs to go on the market early, in order to save the lives of people with a short time to live, Bennett says. People with advanced cancer are often willing to accept a higher level of risk - and the potential for serious side effects - if they have no other hope for extending their lives, he says.

"We're not talking about people with skin conditions," Bennett says. "These people are going to die."

Bennett notes that none of the cancer drugs given accelerated approval were recalled for safety.

Although the program began well, its progress has stalled in recent years, Bennett says.

When the program began, the FDA approved many drugs based on smaller studies without comparison groups. Today, the agency prefers that companies perform larger studies with comparison groups, although it may accept interim results, says the FDA's Richard Pazdur.

Only these kinds of large studies can show if drugs have rare but serious side effects, Pazdur says. They provide other important information as well, such as how long patients live before their tumors get worse.

But with so many more patients, these large-scale studies, which measure results such as overall survival, may cost more than $600 million and take an additional five years to complete, Bennett says. Many small biotech companies can't afford to spend that much. And patients may not be able to wait that long, he says.

Pazdur says patients have other ways to get early access to promising drugs.

Through an expanded access program, the FDA allows patients and their doctors to apply for unapproved cancer drugs from manufacturers, who may charge for the experimental therapies, he says.

Pazdur says Bennett's study underestimates the number of newly approved cancer drugs because Bennett didn't include cancer drugs that have been greenlighted for several different diseases.

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