Just 43 Percent of Cancer Drugs Greenlit Under FDA’s Accelerated Approval Process Had Confirmed Benefit

A new study into the U.S. Food and Drug Administration’s (FDA) accelerated medicine approval process found that just 43 percent of the cancer drugs launched under the program between 2013–2017 demonstrated a confirmed clinical benefit, even though 63 percent of them were converted to regular approval. The FDA established its accelerated approval pathway over 30 years ago to allow for earlier approval of drugs that treat serious conditions such as HIV, with roughly 85 percent of accelerated approvals nowadays going to cancer drugs. Any pharmaceuticals that are approved under the accelerated program must undergo follow-up trials to confirm that they deliver the promised clinical benefit....