# Indication withdrawal

Source: https://onco.cc/terms/approval-withdrawal/  
OnCo record `approval-withdrawal` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

When a drug's approval for a particular cancer is cancelled, usually because the confirmatory trial failed to show benefit, sometimes because of safety. The drug may stay on the market for its other uses, and occasionally an indication is later re-approved on new data.

## Summary

Withdrawals cluster around accelerated approvals: atezolizumab and pembrolizumab in some bladder and gastric settings (2021), PI3K inhibitors idelalisib, duvelisib, umbralisib and copanlisib in lymphoma (2022-23), melphalan flufenamide, ibrutinib in mantle cell and marginal zone lymphoma (2023), and tazemetostat (2026). Belantamab mafodotin was withdrawn in 2022 and re-approved in 2025 after DREAMM-7/8. Withdrawals are usually 'voluntary' at the FDA's request; formal revocation is rare and slow. Patients already benefiting are typically allowed to continue, and the drug often remains approved in other regions.

## Fields

- Kind: Term
- Last checked: 2026-09-09
- Also known as: withdrawn; voluntary withdrawal; voluntarily withdrawn; withdrawn indication; withdrawn from the US market; withdrawn in the US; market withdrawal; indication withdrawn; re-approved; re-approval; reapproved

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Drug_withdrawal
- Wikipedia: https://en.wikipedia.org/wiki/Drug_withdrawal

## Connected records

- terms: [Accelerated approval](https://onco.cc/terms/accelerated-approval/), [Cancer Drugs Fund (England)](https://onco.cc/terms/cancer-drugs-fund/), [Conditional marketing authorisation (EU)](https://onco.cc/terms/conditional-approval/), [Confirmatory trial](https://onco.cc/terms/confirmatory-trial/), [FDORA 2022 accelerated approval reforms](https://onco.cc/terms/fdora-2022/), [Full (traditional, regular) approval](https://onco.cc/terms/full-approval/), [Medicare coverage with evidence development](https://onco.cc/terms/medicare-ced/), [ODAC (Oncologic Drugs Advisory Committee)](https://onco.cc/terms/odac/), [Regulation (EC) No 726/2004: the EU centralised procedure](https://onco.cc/terms/eu-regulation-726-2004/)
- fronts: [Drug Discovery Platforms](https://onco.cc/fronts/drug-discovery/)
- drugs: [Belantamab mafodotin](https://onco.cc/drugs/belantamab-mafodotin/), [Copanlisib](https://onco.cc/drugs/copanlisib/), [Duvelisib](https://onco.cc/drugs/duvelisib/), [Idelalisib](https://onco.cc/drugs/idelalisib/), [Tazemetostat](https://onco.cc/drugs/tazemetostat/), [Umbralisib](https://onco.cc/drugs/umbralisib/)

---
JSON: https://onco.cc/api/v1/entities/approval-withdrawal.json