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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.
Non-covalent, highly selective BTK inhibitor occupying the ATP site independent of C481, with a long half-life for continuous occupancy. Connects to BTK (Bruton tyrosine kinase).
1.Pirtobrutinib binds the BTK ATP pocket reversibly and tightly
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
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. Prior covalent BTK inhibitor required, per the label.
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 TA1173. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
| Date | Deal | Type | Upfront | Total | Source |
|---|---|---|---|---|---|
| 2019-01-07 | Loxo Oncology to Eli Lilly (incl. Loxo) LOXO-292 (selpercatinib, Retevmo) and LOXO-305 (pirtobrutinib, Jaypirca) | Acquisition | not disclosed | $8.0bn | source |
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Adult patients with relapsed or refractory mantle cel lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor.
Accelerated approval on a surrogate endpoint; the confirmatory requirement was still open 3.6 years later, when the FDA's table was read. source
Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
CLL/SLL accelerated approval
Adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor
Confirmed: the accelerated approval of 2023 converted to traditional approval 2.0 years after it was granted. source
Traditional approval; label broadened to any prior covalent BTKi source
| 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.
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Query 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.
Shares Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL), Richter transformation, MIPI (Mantle Cell Lymphoma International Prognostic Index), BTK resistance mutations: C481S, and L528W and T474I after the non-covalent inhibitors.
Shares Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL), MIPI (Mantle Cell Lymphoma International Prognostic Index), BTK resistance mutations: C481S, and L528W and T474I after the non-covalent inhibitors, BTK C481S, PLCG2 and BCL2 G101V resistance mutations.
Shares A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL), Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL), MIPI (Mantle Cell Lymphoma International Prognostic Index), ZUMA-2: brexu-cel CAR-T for mantle cell lymphoma that has failed BTK inhibitors.
Shares CaDAnCe-304, BTK (Bruton tyrosine kinase), Acquired resistance to every therapy, Mantle cell lymphoma.
Shares BTK resistance mutations: C481S, and L528W and T474I after the non-covalent inhibitors, BTK C481S, PLCG2 and BCL2 G101V resistance mutations, Mantle cell lymphoma, Chronic lymphocytic leukaemia.
Shares BTK resistance mutations: C481S, and L528W and T474I after the non-covalent inhibitors, BTK C481S, PLCG2 and BCL2 G101V resistance mutations, Relapsed or refractory chronic lymphocytic leukaemia, BTK (Bruton tyrosine kinase).
Shares Richter transformation of chronic lymphocytic leukaemia, Relapsed or refractory chronic lymphocytic leukaemia, Eli Lilly (incl. Loxo), Chronic lymphocytic leukaemia.
Shares Relapsed or refractory chronic lymphocytic leukaemia, BTK (Bruton tyrosine kinase), Mantle cell lymphoma, Chronic lymphocytic leukaemia.