The process of advancing a drug through the various stages of research, clearing it with regulators and bringing it to market takes years, if not decades.
But in diseases like cancer that are deadly, fast-progressing or both, patients typically can’t wait that long. So to help get new treatments for serious illnesses to patients faster, the FDA has for the past 30 years been allowed to issue accelerated approvals, which are often based on much smaller amounts of evidence and surrogate measures of patient health.
Though it has ushered effective therapies to market, the accelerated approval pathway has also come under fire. In some cases, the trials meant to confirm these drugs work as intended were never completed, or produced negative results.
