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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 Approved 2018 (CLL/SLL after 2 lines; FL accelerated, withdrawn 2021).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).
Dual inhibition of PI3K delta (malignant B cells) and gamma (T cells, macrophages in the microenvironment). Connects to PIK3CA / PI3K-alpha.
1.Duvelisib slips into a pocket on PIK3CA / PI3K-alpha.
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).
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.
Sources: NICE search: duvelisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
Treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after at least 2 prior systemic therapies
Withdrawn: the indication came off the label 3.2 years after its accelerated approval.
| 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| US | 2018 | Relapsed/refractory CLL/SLL after ≥2 prior therapies; FL (withdrawn 2021) |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 |
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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.
Shares PI3K delta (PIK3CD), Indication withdrawal, Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination, PIK3CA / PI3K-alpha.
Shares PI3K delta (PIK3CD), Indication withdrawal, Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination, PIK3CA / PI3K-alpha.
Shares Indication withdrawal, PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Chronic lymphocytic leukaemia.
Shares Infection prophylaxis in lymphoma: PJP, herpes, fungal risk and vaccination, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma), Chronic lymphocytic leukaemia.
Shares PIK3CA / PI3K-alpha, PI3K / AKT / mTOR.
Shares PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Small-molecule kinase inhibitors.
Shares PIK3CA / PI3K-alpha, Small-molecule kinase inhibitors.