OnCo
drugsProductNot mapped hereapproved

Duvelisib

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

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 Approved 2018 (CLL/SLL after 2 lines; FL accelerated, withdrawn 2021).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).

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Duvelisib
PubChem
Modality
Small-molecule PI3Kδ/γ inhibitor
Mechanism
Dual inhibition of PI3K delta (malignant B cells) and gamma (T cells, macrophages in the microenvironment).
Brand / code
Copiktra
Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Two or more prior therapies for CLL/SLL.

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

Not appraisedSearch NICE
Notes
EU marketing authorisation application withdrawn; no UK licence.
NHS England
Not routinely funded

Sources: NICE search: duvelisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2018Relapsed/refractory CLL/SLL after ≥2 prior therapies; FL (withdrawn 2021)
EU2021CLL after ≥2 therapies; FL after ≥2 therapies

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
34 studies7 recruiting29 Phase 25 Phase 3
Search “Duvelisib” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Duvelisib
intervention: Duvelisib
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Duvelisib" OR ABSTRACT:"Duvelisib" OR TITLE:"Copiktra" OR ABSTRACT:"Copiktra") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Duvelisib, not a curated reading list.

Connected

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