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# FDA Lauds its Success in Accelerated Cancer Drug OKs
- URL: https://www.fdaweb.com/fda-lauds-its-success-in-accelerated-cancer-drug-oks/
- Published: 2018-03-05T12:00:00.000Z
- Updated: 2026-09-14T23:27:23.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140898

An FDA review of cancer drugs that used the accelerated approval program has found that very few of the resulting indications failed to verify clinical benefit in required confirmatory trials. The review covered the past 25 years and concluded with high marks for the program, according to agency officials writing in [*JAMA Oncology*](https://jamanetwork.com/journals/jamaoncology/article-abstract/2673837?redirect=true&ref=fdaweb.com). However, they noted that five (5%) indications receiving accelerated approval have been withdrawn from the market, and 37 (40%) of accelerated oncologic indications have not yet completed confirmatory trials or verified their benefit. Of the 93 oncologic accelerated approvals granted since 1992, 51 (55%) have fulfilled their postmarketing requirement and verified benefit in a median 3.4 years after initial approval, they wrote.  

The FDA officials noted that end point of response rate, including hematologic response rates, accounted for most (87%) accelerated approvals, for oncologic drugs, followed by time-to-event end points of progression-free survival or time to progression (9%) and disease-free survival or recurrence-free survival (4%). Single-arm trial designs provided the data for 72% of the initial indications, they wrote.