FDA Committee Meets to Reconsider Accelerated Approvals of Cancer Drugs

On April 27, the U.S. Food and Drug Administration’s (FDA’s) Oncologic Drugs Advisory Committee began its first meeting in a decade to reconsider accelerated approvals of various cancer drugs that have failed to verify benefit in follow-up clinical trials.

“Doctors are using these drugs and patients are receiving them with all their toxicities and without knowing whether they actually doing anything,” said Ezekiel Emanuel, MD, PhD, cancer specialist and bioethicist at the University of Pennsylvania. “We should not be in a situation where we’re endlessly uncertain.”

While only 5% of accelerated approvals for cancer drugs have been withdrawn since the program’s inception in 1992, a study published in JAMA Internal Medicine found that only about 20% of treatments had been shown to extend lives in follow-up studies. The FDA has allowed manufacturers to confirm the benefits of their drugs through a second study of a preliminary measure, such as delayed tumor growth or tumor shrinkage.

While the FDA’s role is to consider the effectiveness of drugs rather than the cost, U.S. spending on cancer drugs has more than doubled since 2013, ballooning to $60 billion per year and rising much faster than patient survival rates, according to IQVIA, a health care data firm.

This meeting is part of an industry-wide evaluation of such cases triggered by what FDA officials call an “unprecedented level of drug development” in recent years.

Source: AP News, April 25, 2021.