Floatz Rating
BB65/100
Confidence
Indicative
Sponsor
Fondazione Italiana Linfomi - ETS
Modality
Small molecule
Development Phase
Phase 3
Status
Active
Evidence ledger · v0.2
Clinical Evidence
Clinical track record: trial progression, reported outcomes, safety signals, and endpoint quality.
65High confidence
Detailed axis rationale is planned and will be published soon.
| Trial | Phase | Status | N | Primary endpoint | Readout |
|---|---|---|---|---|---|
NCT07207785CT.gov PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma | — | Not Yet Recruiting | — | — | — |
NCT07285590CT.gov Clinical Trial to Evaluate the Efficacy and Safety of Pirtobrutinib With Rituximab in Patients With Mantle Cell Lymphoma | — | Recruiting | — | — | — |
NCT05990465CT.gov LV20.19 CAR T-Cells in Combination With Pirtobrutinib for Relapsed, Refractory B-cell Malignancies | — | Recruiting | — | — | — |
NCT06522386CT.gov GATE1: A Multicenter Phase II Study of Pirtobrutinib, Rituximab and Venetoclax Combination Therapy for Patients With Previously Untreated Mantle Cell Lymphoma | — | Active Not Recruiting | — | — | — |
NCT06553872CT.gov Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL | — | Recruiting | — | — | — |
NCT06252675CT.gov Glofitamab With Pirtobrutinib for Relapsed or Refractory Mantle Cell Lymphoma | — | Recruiting | — | — | — |
NCT06263491CT.gov Phase II Study of Pirtobrutinib, Rituximab (PR) in Previously Untreated Low and Intermediate Risk MCL (Mantle Cell Lymphoma) Patients | — | Recruiting | — | — | — |
NCT05833763CT.gov A Phase 2 Trial of GlOfitamab anD pIrtobrutinib in Mantle Cell Lymphoma Patients With Prior BTK Inhibitor Exposure. | — | Recruiting | — | — | — |
NCT05529069CT.gov Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients | — | Recruiting | — | — | — |
NCT05024045CT.gov Study of Oral LOXO-338 in Patients With Advanced Blood Cancers | — | Active Not Recruiting | — | — | — |
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NCT04849416CT.gov A Study of LOXO-305 in Chinese Participants With Blood Cancer (Including Lymphoma and Chronic Leukemia) | — | Completed | — | — | — |
NCT04662255CT.gov Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) | — | Active Not Recruiting | — | — | — |
NCT03740529CT.gov A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL | — | Completed | — | — | — |
NCT05172700CT.gov Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer | — | Approved For Marketing | — | — | — |
Competitive Position
Competitive setting: how crowded the indication is, class-level failures, and timing against rivals.
65High confidence
Detailed axis rationale is planned and will be published soon.
Same indication · Mantle Cell Lymphoma
| Asset | Sponsor | Phase | Rating |
|---|---|---|---|
| Pirtobrutinib (this asset) | Fondazione Italiana Linfomi - ETS | P3 | BB · 65 |
| Etoposide | Ruijin Hospital | P4 | BBB |
| Cis-Diamminedichloroplatinum Ii | National Cancer Institute (NCI) | P4 | BBB |
| Vincristine Sulfate | M.D. Anderson Cancer Center | P2 | BBB |
| Cyclosporin A | Fred Hutchinson Cancer Center | P3 | BBB |
| Irinotecan | University of Michigan Rogel Cancer Center | P2 | BBB |
| Busulfanum | City of Hope Medical Center | P2 | BBB |
| Cediranib | City of Hope Medical Center | P2 | BB |
| Rituximab | City of Hope Medical Center | P4 | BB |
+42 more in the Mantle Cell Lymphoma cohort
Other indications for Pirtobrutinib
| Indication | Sponsor | Phase | Rating |
|---|---|---|---|
| Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | — | P4 | BB · 68 |
| B-Cell Non-Hodgkin Lymphoma | — | P3 | BB · 68 |
| Non-Hodgkin Lymphoma | — | P4 | BB · 67 |
Scientific Foundation
Strength of the underlying biology: target validation, tractability, modality fit, and how related mechanisms have fared.
NR
Planned for methodology v0.2.
Development Feasibility
How realistically the program can be executed, drawing on modality precedent, enrollment dynamics, and sponsor delivery.
NR
Planned for methodology v0.2.
Commercial Opportunity
Commercial prize: addressable population, unmet need, and the value case for the indication.
NR
Planned for methodology v0.2.
IP & Exclusivity
Exclusivity position, covering patent protection and freedom-to-operate runway.
NR
Planned for methodology v0.2.
Manufacturing & Supply
Manufacturing and supply readiness, driven by modality process and scale-up risk.
NR
Planned for methodology v0.2.
Related assets
Citation
Floatz Terminal. Pirtobrutinib in Mantle Cell Lymphoma. Methodology v0.2. Rated under v0.2 effective July 8, 2026. Last refreshed July 8, 2026. Accessed July 14, 2026. https://terminal.floatz.ai/assets/pirtobrutinib-mantle-cell-lymphoma
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