Therapy Detail
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| Therapy Name | Pirtobrutinib |
| Synonyms | |
| Therapy Description |
Jaypirca (pirtobrutinib) selectively inhibits the activation of BTK, which may results 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 (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 35 | Jaypirca (pirtobrutinib) selectively inhibits the activation of BTK, which may results 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 (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 |
|---|---|---|---|---|---|---|
| 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 | ITA | GBR | FRA | AUS | 5 |
| 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) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 16 |
| 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) | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 13 |
| 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) | Recruiting | USA | ITA | GBR | FRA | ESP | AUT | AUS | 14 |
| NCT05172700 | Expanded access | Pirtobrutinib | Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer | Available | 0 | |
| 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 | Recruiting | USA | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS | 14 |
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