Approved Early, Proven Later? What Happens to Cancer Accelerated Approvals

When the FDA grants a cancer drug "accelerated approval," what happens to it next? We wanted to know how often the drug goes on to earn full approval, how many fail and are withdrawn, how many are still waiting for a verdict, and how long each of those outcomes takes.

What is accelerated approval?

Accelerated approval lets the FDA clear a drug early, based on an encouraging early signal such as tumors shrinking, instead of waiting years for proof that patients live longer. The FDA created the program for drugs that treat serious conditions with few good options. It calls the early signal a surrogate endpoint, a measure "thought to predict clinical benefit" that does not prove it. Approving a drug on that signal, instead of waiting for survival data, can get it to patients much sooner, and that matters most when the cancer moves fast ^[1]. In return, the company agrees to run a confirmatory trial that shows a real benefit.

The FDA tracks what happens next through its Project Confirm lists, which cover every oncology accelerated approval since the FDA started granting them in 1992 ^[2]. Each approval is on one of three lists: converted to full approval, withdrawn, or still ongoing ^[3–5].

How many accelerated approvals convert to full approval?

Most oncology accelerated approvals do go on to full approval. The FDA's lists hold 219 oncology accelerated approvals, counted by indication, so a drug approved early for two cancers counts twice. Of those, 127 (58%) have been converted to full approval, 57 (26%) are still waiting for a verdict, and 35 (16%) have been withdrawn ^[3–5].

Does full approval mean the drug works?

When a confirmatory trial succeeds, the FDA can convert the drug to full approval. But a confirmatory trial can succeed by moving another stand-in measure, such as slower tumor growth, so a drug can earn full approval without ever showing that patients live longer or feel better. (If you want the background on these measures, our guide on how to read a cancer trial walks through each one.)

A 2024 study in JAMA measured that gap for 46 oncology accelerated approvals granted from 2013 to 2017. It found that 29 (63%) had been converted to full approval, but only 20 (43%) had shown a clinical benefit in their confirmatory trials ^[6].

A 2015 study of 36 cancer drug approvals from 2008 to 2012 that rested on a stand-in measure found that only 5 (14%) went on to show that patients lived longer ^[7]. The two studies looked at different groups of drugs, so their numbers should not be read as a trend.

How long does it take to confirm an accelerated approval?

Drugs that convert to full approval get there in a median of about 3.3 years. Approvals that end up withdrawn take a little longer to unwind, a median of about 3.8 years, and a few hang on far longer than that ^{[3, 4]}.

Why is it hard to confirm an accelerated approval?

Much of the difficulty comes from timing. Once a drug is approved, doctors can prescribe it outside a trial, which makes it harder to enroll patients in a randomized confirmatory trial. The FDA's 2023 guidance on cancer drugs says that waiting to start that trial until after approval "can create challenges in enrolling participants due to the availability of the drug in clinical practice." It recommends that the trial be well underway, if not fully enrolled, by the time of approval ^[8].

The FDA's own numbers show how much that matters. In an analysis presented at its November 2023 advisory committee meeting, approvals whose confirmatory trial was already underway reached full approval or withdrawal in a median of 3.1 years. For approvals whose trial had not yet started, the median was 7.3 years ^[9].

Rare cancers add to the problem, because there are few patients to enroll. For pralatrexate in peripheral T-cell lymphoma, the first confirmatory trials had to be released and reissued because of poor enrollment ^[9].

Congress has since given the FDA more power over late trials. Under the Consolidated Appropriations Act, 2023, the FDA can now require a confirmatory trial to be underway before it grants accelerated approval, as its 2024 guidance explains. Companies must also report on those trials about every 180 days. If a trial fails, or the company does not pursue it with due diligence, the FDA can withdraw the approval through faster procedures ^[10].

Which accelerated approvals were confirmed, and how fast?

Of the 127 drugs that converted, 61 got full approval two to five years after their early approval. Another 32 got there in less than two years, and 34 took more than five ^[3].

The fastest was ibrutinib (Imbruvica) for chronic lymphocytic leukemia, fully approved about five and a half months after its accelerated approval in 2014. The slowest was clofarabine (Clolar), approved early in 2004 for children and young adults with relapsed acute lymphoblastic leukemia and not fully approved until July 2022, more than seventeen and a half years later. Next came nelarabine (Arranon) for T-cell acute lymphoblastic leukemia, at almost fourteen years ^[3].

Last 5 years (19)Last 10 years (65)Last 15 years (88)All since 1995 (127)

Which cancer drugs are still waiting for confirmation?

The FDA lists 57 oncology accelerated approvals that are still waiting for their confirmatory answer ^[5]. The two that have waited longest both treat peripheral T-cell lymphoma, a rare and aggressive blood cancer. Folotyn (pralatrexate) was approved in 2009 ^[11], and Beleodaq (belinostat) in 2014 ^[5].

At a November 2023 advisory committee meeting, FDA reviewers used these two drugs as their case study in confirmatory trials that run late ^{[9, 12]}. The FDA projects the final report in 2030, which it noted is 21 years after pralatrexate's approval and 16 years after belinostat's ^[9]. Among the reasons it listed were a change of ownership and a confirmatory trial that did not start until October 2023. The trial's target date for enrolling its first quarter of patients moved from April 2017 to April 2026 ^[9].

Waiting 5+ years (17)3 to 5 years (14)Under 3 years (26)All (57)

Which accelerated approvals were withdrawn?

When a confirmatory trial fails, or the company does not finish it, the accelerated approval is withdrawn. About one in six oncology accelerated approvals have ended this way (35 of 219), after anywhere from about a year to more than twelve years on the market ^[4]. Umbralisib (Ukoniq) was pulled about sixteen months after approval, after updated results from its UNITY-CLL trial showed a possible increased risk of death ^[13]. At the other end, the celecoxib (Celebrex) approval for familial adenomatous polyposis, a rare precancerous condition, stayed on the label for more than twelve years ^[4].

The withdrawals bunch together in time, with 14 of the 35 coming in 2021 and 2022 ^[4]. That cluster overlaps with the FDA's 2021 review of "dangling" accelerated approvals for checkpoint inhibitors, in which companies withdrew several indications and an April 2021 advisory committee recommended pulling two more ^[14].

All (35)2021 to 2022 (14)Since 2023 (13)Before 2021 (8)

Which companies have the most cancer accelerated approvals?

Grouping the approvals by company shows which drugmakers have the most and how many of those each one has confirmed. We credit each drug to the company that holds its FDA application today, rolled up to its parent company ^[3–5].

• Bristol Myers Squibb has the most, 26, carried by Opdivo and drugs it inherited from Celgene. Of those, 16 are converted, 6 are still pending and 4 were withdrawn.
• Novartis has 24, with 19 converted and none withdrawn.
• Merck has confirmed 16 of its 19, with 2 withdrawn.
• Roche has 4 withdrawals, tied with Bristol Myers Squibb for the most, and three of Roche's are Tecentriq indications.
• Johnson & Johnson and Amgen have no withdrawals so far.

A fairer way to compare how companies convert is to count only the approvals that already have a verdict, because recent approvals have not had time to convert yet. Across all companies, 127 of 162 decided approvals were converted, or 78%. Novartis has converted all 19 of its decided approvals, Pfizer 10 of 11, Lilly 10 of 11, Merck 16 of 18 and Bristol Myers Squibb 16 of 20. Roche is the exception, with only 4 of its 8 decided approvals converted and the other 4 withdrawn ^[3–5].

Because the chart follows today's FDA application holder, acquisitions count toward the buyer: seven of Bristol Myers Squibb's 26 came from Celgene (Pomalyst, Thalomid, Istodax and Breyanzi), and five of Pfizer's 13 came through Seagen and Array. Partnered drugs count toward the partner that holds the application, so Enhertu and Datroway are credited to Daiichi Sankyo rather than AstraZeneca, and Padcev to Astellas rather than Pfizer. A withdrawal is also not always a failure of effort, since some reflect how hard a cancer is to treat rather than a company that gave up.

Which cancer drugs have the most accelerated approvals?

Keytruda has more oncology accelerated approvals than any other drug, 18 in all. Of those, 15 have converted to full approval, 1 is still waiting and 2 were withdrawn. Opdivo is next with 11, of which 9 converted and 2 were withdrawn ^[3–5].

Those four withdrawals, for small cell lung, gastric and liver cancers, came between December 2020 and February 2022. An April 2021 advisory committee voted against keeping Keytruda's approval for gastric cancer and Opdivo's for liver cancer ^{[4, 14]}.

All 6 of Gleevec's accelerated approvals converted, as did all 4 of Retevmo's. All 3 of Tecentriq's were withdrawn, and all 3 of Brukinsa's are still waiting ^[3–5].

Search all 219 cancer accelerated approvals

The table below lists every oncology accelerated approval on the FDA's lists. You can search by drug, company or cancer, filter by outcome or company, and sort by any column. Drug and company names link to their pages on TheraRadar.

How to read an accelerated approval

For a patient with an aggressive cancer and few options, getting a promising drug years early is a real benefit, and most of these drugs do go on to convert. When you read that a cancer drug is "approved," three questions tell you how much proof is behind it: whether the approval is accelerated or full, what measure it rests on, and whether the confirmatory trial has reported yet.

It would also be good to know whether the three groups differ in clear ways: the drugs that converted, the ones that were withdrawn and the ones still waiting. They might differ in the type of drug, the cancer it treats or the early evidence behind the approval, and we will look at that in a future brief.

About the data. Counts, medians, timelines and company records are computed from the FDA's three Project Confirm lists, counted by indication, with content current as of September 17, 2026 (withdrawn list: September 2, 2026). We checked every row (drug, accelerated approval date, and conversion or withdrawal date) against the FDA lists on October 1, 2026. Each drug is credited to the company that holds its FDA application today (openFDA Drugs@FDA and the Purple Book, September 2026), rolled up to its parent company. This is an educational reference and does not constitute medical advice. If you spot an error, please email us at hello@theraradar.com.