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A new study has found that 41 percent of cancer drugs receiving accelerated government approval do not improve survival or quality of life.
The U.S. Food and Drug Administration's (FDA's) accelerated approval program aims to get new drugs to patients as quickly as possible. But the effectiveness of the drugs differs.
The program was created in 1992 to speed up the approval of HIV drugs. Today, about 85 percent of accelerated approvals go to cancer drugs.
The program helps the FDA collect data on early results of approved drugs. In exchange, drug companies are expected to use the data to do additional testing. They are to produce better evidence before drugs receive normal approval.
The new study suggests most cancer drugs given accelerated approval do not improve or extend patients' lives within five years.
Dr. Ezekiel Emanuel is a cancer specialist and bioethicist at the University of Pennsylvania. He was not involved in the research.
Emanuel told The Associated Press (AP) he thinks five years should be enough time to examine the effectiveness of new drugs. "Thousands of people are getting those drugs. That seems a mistake if we don't know whether they work or not," he added.
It is up to the FDA or the drug company to withdraw drugs that do not perform well. Sometimes the FDA decides that less clear evidence is good enough to give full approval.
The new study found that between 2013 and 2017, 46 cancer drugs were given accelerated approval. Of those, 63 percent were moved to normal approval. Forty-three percent demonstrated a good medical result in tests.
The study was published in the Journal of the American Medical Association. It was also discussed at the recent meeting of the American Association for Cancer Research in San Diego, California.
Dr. Edward Cliff of Harvard Medical School was a co-writer of the study. He told the AP it is unclear how much cancer patients understand about drugs with accelerated approval. "We raise the question: Is that uncertainty being conveyed to patients?" he said.
Drugs that received accelerated approval may be the only chance for patients with rare or advanced cancers, said Dr. Jennifer Litton. She is with the MD Anderson Cancer Center in Houston, Texas. Litton, who was not involved with the study, said it is important for doctors to carefully explain the evidence.
"It might be shrinking of tumor. It might be how long the tumor stays stable," Litton said. "You can provide the data you have, but you shouldn't overpromise."
Congress recently changed the program to give the FDA more power and to simplify the process of withdrawing drugs when companies do not meet their commitments.
The changes permit the FDA "to withdraw approval for a drug approved under accelerated approval, when appropriate, more quickly," said FDA spokesperson Cherie Duvall-Jones. The agency can now require that confirmatory tests be started when the agency gives the first approval. This can speed up the process of confirming how effective a drug is, Duvall-Jones said.
Words in This Story
accelerate – v. speed up the process of something
bioethicist – n. someone who studies questions of right or wrong relating to new discoveries and methods in biology and medicine
convey – v. to express a thought, feeling or idea so that it is understood by other people
advanced –adj. having developed for a long time or to a high degree
tumor – n. a mass of diseased cells that might become a lump or cause sickness
stable – adj. firmly fixed or not likely to move or change
commitment – n. a promise of firm decision to do something
appropriate – adj. suitable or right for a particular situation
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