FDA publishes review of cancer accelerated approvals

Over half of all cancer therapies approved under FDA’s accelerated assessment pathway since its inception have verified their clinical benefit, according to a review from FDA's Office of Hematology and Oncology Products published in JAMA Oncology. The authors also found that the use of the program has increased over time.

The accelerated approval program is designed to speed approval of treatments that may offer an advantage over available therapies for serious or life-threatening diseases, typically before confirmatory trials are completed...