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# Accelerated Approval Works: Friends of Cancer Research
- URL: https://www.fdaweb.com/accelerated-approval-works-friends-of-cancer-research/
- Published: 2025-05-22T12:00:00.000Z
- Updated: 2026-09-14T15:12:30.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5159227

A Friends of Cancer Research online analysis of data from the FDA accelerated approval (AA) program says it “remains a critical tool for expediting access to promising drugs in areas of unmet clinical need.” The majority of AAs (54%) ultimately receive full approval, the [report](https://friendsofcancerresearch.org/blog/30-years-of-accelerated-approval-trends-timelines-and-impact/?ref=fdaweb.com) says, with verification of benefit occurring at a median of less than four years for most drugs.

The organization’s researchers analyzed data on the 344 original and supplemental AAs granted from 6/1992 to 12/2024\. They say they identified trends in approvals, postmarket actions, and the timelines for confirmatory trials.

The number of approvals through the AA program has increased over time, the report says, with notable shifts in the types of drugs receiving the approval.

The researchers found that in addition to the 54% of AAs that were converted to full approval, 13% were withdrawn, and 32% are still classified as “ongoing.” Some 55% of the “ongoing” drugs were granted AA within the last four years, and 79% were granted AA in the last five years, suggesting, the report says, that most ongoing AAs are progressing through confirmatory trials within expected timelines rather than remaining on the market for an extended period without action.

The report says the researchers found that both the median time to AA verification and time to withdrawal have decreased. Likewise, it says, the estimated time to complete confirmatory trial postmarketing reports has steadily decreased in recent years. “These improvements suggest that scientific advancements, policy refinements, and regulatory learnings have contributed to a more efficient and predictable AA process,” the report concludes.