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 36 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 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...
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...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
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 | NZL | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 12
NCT05172700 Expanded access Pirtobrutinib Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer Available 0
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 | NZL | NLD | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14
NCT06333262 Phase II Obinutuzumab + Pirtobrutinib Pirtobrutinib Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia Recruiting USA 0
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 | NZL | ITA | GBR | FRA | ESP | AUT | AUS 13
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 | ITA | GBR | FRA | ESP | DEU | CAN | BEL | AUT | AUS 14
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


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