# Duvelisib

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

## TL;DR

A dual PI3K inhibitor for relapsed CLL whose survival data raised FDA concern; use is now limited to late lines.

## Summary

DUO (2018): PFS 13.3 vs 9.9 months versus ofatumumab in relapsed CLL. Approved 2018 (CLL/SLL after 2 lines; FL accelerated, withdrawn 2021). A 2022 FDA review found a possible increase in deaths; boxed warnings for infections, diarrhoea/colitis, cutaneous reactions and pneumonitis. Studied in PTCL (PRIMO).

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-08
- Tags: gap-fill
- Brand: Copiktra
- Modality: Small-molecule PI3Kδ/γ inhibitor
- Mechanism: Dual inhibition of PI3K delta (malignant B cells) and gamma (T cells, macrophages in the microenvironment).
- Approvals: US 2018: Relapsed/refractory CLL/SLL after ≥2 prior therapies; FL (withdrawn 2021); EU 2021: CLL after ≥2 therapies; FL after ≥2 therapies

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Duvelisib
- Label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=duvelisib

## Connected records

- cancers: [Chronic lymphocytic leukaemia](https://onco.cc/cancers/cll/), [Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma)](https://onco.cc/cancers/peripheral-t-cell-lymphoma/)
- technologies: [Small-molecule kinase inhibitors](https://onco.cc/technologies/kinase-inhibitors/)
- targets: [PI3K delta (PIK3CD)](https://onco.cc/targets/pik3cd/), [PIK3CA / PI3K-alpha](https://onco.cc/targets/pik3ca/)
- companies: [Infinity Pharmaceuticals](https://onco.cc/companies/infinity-pharmaceuticals/), [SecuraBio](https://onco.cc/companies/securabio/)
- pathways: [PI3K / AKT / mTOR](https://onco.cc/pathways/pi3k-akt-mtor/)
- trials: [A Study of Duvelisib Versus Gemcitabine or Bendamustine in Participants With Relapsed/Refractory Nodal T Cell Lymphoma With T Follicular Helper (TFH) Phenotype](https://onco.cc/trials/nct06522737/)
- terms: [Indication withdrawal](https://onco.cc/terms/approval-withdrawal/), [Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination](https://onco.cc/terms/lymphoma-tx-pjp-and-infection-prophylaxis/)

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