Indication withdrawal
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.
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 Belantamab mafodotin was withdrawn in 2022 and re-approved in 2025 after DREAMM-7/8.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.
Pages like this
not linked directly; found by shared links- TermConditional marketing authorisation (EU)
Shares Full (traditional, regular) approval, Confirmatory trial, Accelerated approval.
- TermComplete response letter (CRL)
Shares ODAC (Oncologic Drugs Advisory Committee), Confirmatory trial.
- TargetPIK3CA / PI3K-alpha
Shares Copanlisib, Duvelisib, Umbralisib, Idelalisib.
- TermLabel, indication and label expansion
Shares Full (traditional, regular) approval, Accelerated approval.
- TermSurrogate endpoint
Shares Confirmatory trial, Accelerated approval.
- CancerFollicular lymphoma
Shares Copanlisib, Umbralisib, Idelalisib, Tazemetostat.
- PathwayPI3K / AKT / mTOR
Shares Copanlisib, Duvelisib, Umbralisib, Idelalisib.