Therapy Detail
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| Therapy Name | Pirtobrutinib |
| Synonyms | |
| Therapy Description |
Jaypirca (pirtobrutinib) selectively inhibits the activation of BTK, which may result in decreased tumor growth (PMID: 32170458, PMID: 33676628). Jaypirca (pirtobrutinib) is FDA approved for use in patients with relapsed or refractory mantle cell lymphoma who had received at least two lines of systemic therapy, and in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Pirtobrutinib | Jaypirca | LOXO-305|LOXO 305|LOXO305|RXC005|REDX08608 | BTK inhibitor 38 | Jaypirca (pirtobrutinib) selectively inhibits the activation of BTK, which may result in decreased tumor growth (PMID: 32170458, PMID: 33676628). Jaypirca (pirtobrutinib) is FDA approved for use in patients with relapsed or refractory mantle cell lymphoma who had received at least two lines of systemic therapy, and in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have received at least two prior lines of therapy (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| TP53 loss | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Pirtobrutinib | Guideline | Actionable | Jaypirca (pirtobrutinib) is included in guidelines as second-line or third-line therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma with TP53 loss and for patients with relapsed or refractory disease after prior BTK inhibitor and Venclexta (venetoclax)-based therapy (NCCN.org). | detail... |
| TP53 mutant | chronic lymphocytic leukemia/small lymphocytic lymphoma | sensitive | Pirtobrutinib | Guideline | Actionable | Jaypirca (pirtobrutinib) is included in guidelines as second-line or third-line therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma with a TP53 mutation and for patients with relapsed or refractory disease after prior BTK inhibitor and Venclexta (venetoclax)-based therapy (NCCN.org). | detail... |
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT04666038 | Phase III | Idelalisib + Rituximab Pirtobrutinib Bendamustine + Rituximab | Study of LOXO-305 Versus Investigator's Choice (IdelaR or BR) in Patients With CLL or SLL | Active, not recruiting | USA | TUR | POL | ITA | ISR | IRL | HUN | HRV | GBR | FRA | ESP | DEU | CZE | CHE | CAN | BEL | AUT | AUS | 6 |
| NCT06553872 | Phase II | Brexucabtagene autoleucel Brexucabtagene autoleucel + Pirtobrutinib Pirtobrutinib | Phase 2 Open Label Randomized Study of Pirtobrutinib and Brexucabtagene Autoleucel in R/R MCL | Recruiting | USA | 0 |
| NCT06812715 | Phase II | Pirtobrutinib | Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated with Pirtobrutinib After Previous Treatment with Zanubrutinib (PIPOZA) | Not yet recruiting | AUS | 0 |
| NCT06333262 | Phase II | Obinutuzumab + Pirtobrutinib Pirtobrutinib | Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia | Recruiting | USA | 0 |
| NCT05172700 | Expanded access | Pirtobrutinib | Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer | Approved for marketing | 0 | |
| NCT06839872 | Phase II | Pirtobrutinib Acalabrutinib | A Study to Investigate the Sequencing Strategy of Pirtobrutinib After Disease Progression on First-line Acalabrutinib Treatment for Adult Participants With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (BOSS) | Not yet recruiting | USA | 0 |
| NCT06588478 | Phase II | Pirtobrutinib | A Study Evaluating the Efficacy and Safety of Pirtobrutinib in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma | Recruiting | USA | TUR | SVK | ROU | POL | ITA | HUN | GRC | GBR | FRA | ESP | DNK | DEU | CZE | CAN | BEL | AUS | 1 |
| NCT05023980 | Phase III | Pirtobrutinib Bendamustine + Rituximab | A Study of Pirtobrutinib (LOXO-305) Versus Bendamustine Plus Rituximab (BR) in Untreated Patients With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN CLL-313) | Active, not recruiting | USA | ROU | POL | NZL | ITA | HUN | GBR | FRA | ESP | CZE | BRA | BGR | AUT | AUS | 6 |
| NCT03740529 | Phase Ib/II | Cyclophosphamide + Doxorubicin + Pirtobrutinib + Prednisone + Rituximab + Vincristine Sulfate Pirtobrutinib + Rituximab + Venetoclax Pirtobrutinib + Venetoclax Pirtobrutinib | A Study of Oral LOXO-305 in Patients With Previously Treated CLL/SLL or NHL | Active, not recruiting | USA | SWE | POL | ITA | GBR | FRA | CHE | AUS | 2 |
| NCT04662255 | Phase III | Ibrutinib Zanubrutinib Pirtobrutinib Acalabrutinib | Study of BTK Inhibitor LOXO-305 Versus Approved BTK Inhibitor Drugs in Patients With Mantle Cell Lymphoma (MCL) (BRUIN-MCL-321) | Active, not recruiting | USA | POL | NZL | NLD | ITA | ISR | IRL | HUN | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | AUT | AUS | 6 |
| NCT05254743 | Phase III | Ibrutinib Pirtobrutinib | A Study of Pirtobrutinib (LOXO-305) Versus Ibrutinib in Participants With Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) (BRUIN-CLL-314) | Active, not recruiting | USA | TUR | POL | NZL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG | 5 |
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