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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