Study: 1/3 of Cancer Accelerated Approval Indications Remain Despite Lack of Confirmation

The U.S. Food and Drug Administration (FDA) developed its Accelerated Approval Program in 1992, with the intention of moving certain new drugs to the market faster.

An Accelerated Approval typically leans on a surrogate endpoint, basically a marker, such as a laboratory value, radiographic image, physical sign or other measures that can be used to predict clinical benefit but isn’t by itself a measure of clinical benefits.