Pirtobrutinib
A BTK blocker that works after the older ones stop, because it grips a different part of the enzyme. Fully approved for CLL in December 2025.
Binds BTK reversibly and is active against C481 mutations. BRUIN CLL-321 (n=238, post-covalent BTKi): PFS 11.2 vs 8.7 months vs idelalisib-rituximab or bendamustine-rituximab (HR 0.58), leading to traditional approval on 3 December 2025 after the December 2023 accelerated approval. Also approved in MCL (2023). Frontline trials (BRUIN CLL-313 vs bendamustine-rituximab, CLL-314 vs ibrutinib) and combination with venetoclax (CLL-322) are reading out 2026-27. Resistance via T474I and L528W confers cross-resistance to some covalent inhibitors.
1.Pirtobrutinib binds the BTK ATP pocket reversibly and tightly
- Route
- Oral
- Schedule
- 200 mg once daily continuously
- Monitoring
- Infections, bleeding, cytopenias, atrial fibrillation (low), second primary malignancies
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- 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. Prior covalent BTK inhibitor required, per the label.
- Assistance programmes
- Lilly Cares Foundation
- 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
- Licensed 2023 for mantle cell lymphoma after a BTK inhibitor; NICE recommended it via the CDF in 2024. TA number not verified.
Sources: NICE search: pirtobrutinib. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 1 Dec 2023ApprovalUS
CLL/SLL accelerated approval
- 3 Dec 2025ApprovalUS
Traditional approval; label broadened to any prior covalent BTKi source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Relapsed MCL after BTK inhibitor (accelerated, January); CLL/SLL after BTK and BCL-2 inhibitors (accelerated, December) |
| US | 2025 | Relapsed/refractory CLL/SLL after a covalent BTK inhibitor (traditional approval, BRUIN CLL-321) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Fatigue | 29% | — |
| Neutropenia | — | 16% |
| Atrial fibrillation | 3.7% | — |
| Bruising | 24% | — |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Pirtobrutinib" OR ABSTRACT:"Pirtobrutinib" OR TITLE:"Jaypirca" OR ABSTRACT:"Jaypirca") 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 Pirtobrutinib, not a curated reading list.
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