Idelalisib was the first PI3K inhibitor for blood cancers; it is effective in CLL with rituximab but so toxic (colitis, hepatitis, pneumonitis, infections) that the class has largely been abandoned.
Approved 2014 (CLL with rituximab; FL and SLL accelerated). Trials in earlier lines were halted in 2016 over fatal infections and toxicity; the FL/SLL indications were withdrawn in 2022. Remains an option in relapsed CLL after BTK and BCL2 inhibitors. Its history shaped FDA scepticism of PI3K inhibitors (2022 ODAC).
Selective inhibition of the delta isoform of PI3K, blocking B-cell receptor-driven survival signalling in malignant B cells. Connects to PIK3CA / PI3K-alpha.
1.Idelalisib 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. Restricted to relapsed CLL with rituximab after indication withdrawals.
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 TA359 · SMC advice: idelalisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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For the treatment of relapsed follicular B-cell Non-Hodgkin Lymphoma (FL) in patients who have received at least 2 prior systemic therapies and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapies
Accelerated approval on a surrogate endpoint, with a confirmatory trial required.
For the treatment of relapsed follicular B-cell Non-Hodgkin Lymphoma (FL) in patients who have received at least 2 prior systemic therapies and relapsed small lymphocytic lymphoma (SLL) in patients who have received at least 2 prior systemic therapies
Withdrawn: the indication came off the label 7.6 years after its accelerated approval.
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Relapsed CLL with rituximab; relapsed FL and SLL (accelerated, withdrawn 2022) |
| EU | 2014 | CLL, FL |
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Query for this drug: (TITLE:"Idelalisib" OR ABSTRACT:"Idelalisib" OR TITLE:"Zydelig" OR ABSTRACT:"Zydelig") 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 Idelalisib, 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, Follicular lymphoma.
Shares PI3K delta (PIK3CD), Follicular lymphoma, Chronic lymphocytic leukaemia.
Shares PI3K delta (PIK3CD), Follicular lymphoma, Chronic lymphocytic leukaemia.
Shares Relapsed or refractory chronic lymphocytic leukaemia, Chronic lymphocytic leukaemia, Small-molecule kinase inhibitors.
Shares PI3K delta (PIK3CD), Follicular lymphoma.
Shares Relapsed or refractory chronic lymphocytic leukaemia, Chronic lymphocytic leukaemia, Small-molecule kinase inhibitors.