The FDA and its Oncology Center of Excellence
Cancer medicines in the United States are approved by the Food and Drug Administration, and since 2017 the review has been coordinated by a single Oncology Center of Excellence that cuts across the drug, biologic and device centres. In 2024 it handled 89 oncology drug and biologic approvals and 76 device authorisations.
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The Oncology Center of Excellence was authorised by the 21st Century Cures Act of 2016 and established on 19 January 2017 to unite oncology reviewers across the FDA's drug, biologic and device centres. Its 2024 annual report records 89 oncology drug and biologic product approvals: 19 new molecular entities or new biologics licence applications, 34 new indications for already-approved products and 10 approvals under the 505(b)(2) pathway or as biosimilars, alongside 76 authorised oncology devices and eight drugs or biologics approved for paediatric cancer. Project Orbis, the FDA's concurrent-review arrangement with regulators in Australia, Brazil, Canada, Israel, Singapore, Switzerland and the United Kingdom, contributed to 23 product approvals that year, five of them new products. Project Facilitate processed 761 single-patient expanded-access applications. Richard Pazdur, who had led the FDA's oncology review since 1999, signed that report; R. Angelo de Claro is the centre's director in 2026.
The pathways, and why the FDA is usually first
Priority review gives the agency six months rather than ten. Fast track, breakthrough therapy designation and real-time oncology review change how the conversation runs before the application arrives. Accelerated approval, in place since 1992, lets a drug on the market on a surrogate endpoint. Taken together these are why a new cancer medicine is usually approved in the United States before anywhere else.
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The FDA's own description of priority review is a six-month goal against ten months for standard review, with designation notified within 60 days of receipt; breakthrough therapy designation requires preliminary clinical evidence of substantial improvement over available therapy on a clinically significant endpoint and also carries a 60-day response window; real-time oncology review, given final guidance in November 2023, allows topline efficacy and safety data to be submitted before the full application without changing the statutory clock. The consequence is measurable. Kim and colleagues took all 36 oncology drugs that received their first expedited approval from the FDA between 2019 and 2023 and followed the subsequent decisions of the EMA (28), TGA (18) and PMDA (15): every one of those agencies had a longer review duration than the FDA, the EMA's median submission lag was 27 days and the TGA's exceeded 600. A separate comparison of first-time oncology approvals from 2020 to 2024 counted 73 at the FDA against 56 at the EMA and 18 at Brazil's ANVISA.
Accelerated approval: what happens when the confirmatory trial fails, or never reports
A drug can reach American patients on a tumour-shrinkage result, on the promise that a proper trial will follow. Most of those promises are eventually kept and the approval converts. Some are broken and the indication is withdrawn. And a long tail sits unresolved for years: one indication has been on an accelerated approval since 2009 and is still not settled.
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The FDA publishes four separate tables of oncology accelerated approvals rather than one. Read on 25 September 2026 they held 127 indications whose clinical benefit has been verified and converted to traditional approval, 35 withdrawn, 57 still ongoing, and 20 in an other category covering supportive-care and dosing changes: 239 indications in all since the pathway opened in 1992. Gyawali and colleagues examined the FDA's own review of the first 93 oncology accelerated approvals (December 1992 to May 2017) and found that confirmatory trials demonstrated an improvement in overall survival for 19 of them, one fifth; another fifth reported an improvement in the same surrogate used before approval. Their later analysis of 18 indications whose post-approval trials missed their primary endpoint found 11 voluntarily withdrawn, one revoked by the FDA (bevacizumab with paclitaxel for HER2-negative metastatic breast cancer, accelerated approval 22 February 2008, withdrawal 18 November 2011) and six left on the label. The same paper found the NCCN guidelines still carrying a category 1 endorsement for one of those failed indications and category 2A for seven, in some cases after the approval had been withdrawn or revoked, which under the compendia rule keeps them payable. The Food and Drug Omnibus Reform Act of 2022 responded on the regulatory side: its section 3210 created an Accelerated Approval Coordinating Council, which now reports annually, alongside new withdrawal procedures.
Who was in the trial that won the approval
The evidence base for American cancer approvals does not look like America. Across the 230 trials behind a decade of FDA cancer approvals, Black patients were 3.1 per cent of participants, about a fifth of what their share of the American cancer burden would predict. More than a third of those trials did not report race at all.
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Loree and colleagues examined every reported trial supporting an FDA oncology drug approval granted between July 2008 and June 2018: 230 trials with 112,293 participants. Measured against each group's share of United States cancer incidence, Black patients were at 22 per cent of expected representation and Hispanic patients at 44 per cent, while White patients were at 98 per cent and Asian patients at 438 per cent; in raw shares, 76.3 per cent of participants were White, 18.3 per cent Asian, 6.1 per cent Hispanic and 3.1 per cent Black. Only 145 trials (63.0 per cent) reported at least one race, 18 (7.8 per cent) reported all four major groups, and 58 (25.2 per cent) reported a race subgroup analysis. Comparing the first half of the period with the second, reporting improved a little and enrolment barely moved (Black participants 3.6 against 2.9 per cent). The Food and Drug Omnibus Reform Act of 2022 added sections 505(z) and 520(g) to the Food, Drug and Cosmetic Act, requiring sponsors to submit diversity action plans for pivotal studies; the FDA issued draft guidance in June 2024, replacing an April 2022 draft, and no final guidance had been issued when this page was written.
Every oncology accelerated approval, by what became of it
FDA tables read 2026-09-25The FDA keeps four separate lists rather than one, so the shape of the pathway is not visible from any single page. Put together, 239 oncology indications have been granted accelerated approval since 1992. The medians below are computed from the two date columns of the FDA's own tables; the agency does not publish them.
Median 3.3 years (middle half 1.9 to 5.2)
Median years from accelerated approval to conversion; range across all rows 0.4 to 17.6 years. FDA page current 17 September 2026.
Median 3.8 years (middle half 2.8 to 7.1)
Median years from accelerated approval to withdrawal; the oldest withdrawal came 12.5 years after approval. FDA page current 2 September 2026.
Median 3.3 years (middle half 1.7 to 5.4)
Median years since accelerated approval, still awaiting a confirmatory result. Seventeen have been open more than five years; pralatrexate for peripheral T-cell lymphoma since 24 September 2009. FDA page current 17 September 2026.
Accelerated approvals that are not cancer treatment indications. FDA page current 15 July 2026.
What OnCo holds about United States approvals
290 products carry a sourced United States approval row and 7 a withdrawal, out of 1,088 products in the corpus. An absent row means not yet researched rather than not approved: this count measures our reading, not the FDA's output. The regulatory timeline carries every dated designation, filing, complete response letter and label change we hold, with the weekly FDA feed; approvals by region sets the United States beside the EU, UK, Japan, China, Australia and India.