See the DrugPatentWatch profile for Ceritinib
What happened to ceritinib’s accelerated approval, and when was it withdrawn?
Ceritinib (for ALK-positive metastatic non–small cell lung cancer) had an accelerated approval from the FDA that was later withdrawn after the confirmatory benefit required under the accelerated approval pathway was not demonstrated. The FDA’s withdrawal action and its effective date were published in the Federal Register in 2023. The Federal Register notice is the key official record for the withdrawal timing and rationale. [1]
What does “withdrawn accelerated approval” mean in FDA terms?
When the FDA withdraws an accelerated approval, it is taking action to remove the indication from the market authorization tied to the accelerated approval pathway. This typically follows the FDA’s review of confirmatory trial results, such as whether they verify the clinical benefit that supported initial approval. The Federal Register notice describes the specific basis the FDA used for ceritinib’s indication withdrawal. [1]
Which Federal Register 2023 document should you look up?
Search the 2023 Federal Register for the FDA notice specifically addressing ceritinib’s accelerated approval withdrawal. The citation below is the official Federal Register source you can use to confirm the exact indication, effective date, and the FDA’s stated reason for withdrawal. [1]
Why did FDA withdraw accelerated approvals like this?
The accelerated approval pathway can be granted based on a surrogate endpoint reasonably likely to predict clinical benefit. If confirmatory trials do not verify that benefit, FDA can withdraw the accelerated approval indication. The Federal Register notice for ceritinib explains how the confirmatory evidence did (or did not) meet the requirement. [1]
What should patients and clinicians do after a withdrawal?
After a withdrawal, the indication is no longer authorized under the accelerated approval mechanism described in the original FDA approval. Clinicians typically shift patients to other approved therapies for the same molecularly defined condition, but the specific alternative depends on current labeling, line of therapy, and patient factors. For the exact labeling consequences for ceritinib, the Federal Register notice is the controlling document. [1]
Sources
[1] https://www.federalregister.gov/