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 Approved 2018 (CLL/SLL after 2 lines; FL accelerated, withdrawn 2021).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).
- 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.
- Assistance programmes
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
- Leukemia & Lymphoma Society financial support
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.
- 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- EU marketing authorisation application withdrawn; no UK licence.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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Relapsed/refractory CLL/SLL after ≥2 prior therapies; FL (withdrawn 2021) |
| EU | 2021 | CLL after ≥2 therapies; FL after ≥2 therapies |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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