Idelalisib
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 Trials in earlier lines were halted in 2016 over fatal infections and toxicity; the FL/SLL indications were withdrawn in 2022.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).
- 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. Restricted to relapsed CLL with rituximab after indication withdrawals.
- Assistance programmes
- Gilead Advancing Access
- 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.
- Appraised for
- With rituximab for CLL after 1 prior therapy or untreated with 17p/TP53
- Notes
- Rarely used since BTK and BCL2 inhibitors arrived.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA359 · SMC advice: idelalisib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2014 | Relapsed CLL with rituximab; relapsed FL and SLL (accelerated, withdrawn 2022) |
| EU | 2014 | CLL, FL |
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductUmbralisib
Shares Indication withdrawal, PIK3CA / PI3K-alpha, Follicular lymphoma, PI3K / AKT / mTOR and the tag gap-fill.
- ProductCopanlisib
Shares Indication withdrawal, PIK3CA / PI3K-alpha, Follicular lymphoma, PI3K / AKT / mTOR and the tag gap-fill.
- ProductDuvelisib
Shares Indication withdrawal, PIK3CA / PI3K-alpha, PI3K / AKT / mTOR, Chronic lymphocytic leukaemia and the tag gap-fill.
- ProductTazemetostat
Shares Indication withdrawal, Follicular lymphoma and the tag gap-fill.
- ProductTemsirolimus
Shares PI3K / AKT / mTOR, Small-molecule kinase inhibitors and the tag gap-fill.
- ProductBrexucabtagene autoleucel
Shares Gilead Sciences (incl. Kite) and the tag gap-fill.
- TargetCD73 / adenosine axis
Shares Gilead Sciences (incl. Kite) and the tag gap-fill.
- ProductEnsartinib
Shares Small-molecule kinase inhibitors and the tag gap-fill.