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 mutant chronic lymphocytic leukemia/small lymphocytic lymphoma sensitive Pirtobrutinib Guideline Actionable Jaypirca (pirtobrutinib) is included in guidelines (category 1) as second-line or subsequent therapy for patients with chronic lymphocytic leukemia/small lymphocytic lymphoma with a TP53 mutation and for patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma with a TP53 mutation after prior BTK inhibitor-based and BCL2 inhibitor-containing regimens (NCCN.org). detail...
TP53 loss chronic lymphocytic leukemia/small lymphocytic lymphoma sensitive Pirtobrutinib Guideline Actionable Jaypirca (pirtobrutinib) is included in guidelines (category 1) as second-line or subsequent 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 BCL2 inhibitor-containing therapy (NCCN.org). detail...

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Clinical Trial Phase Therapies Title Recruitment Status Covered Countries Other Countries
NCT06973187 Phase III Pirtobrutinib BGB-16673 A Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Adults With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Recruiting USA | NZL | AUS 1
NCT07218341 Expanded access Pirtobrutinib Idelalisib A Study of Pirtobrutinib (LY3527727) in Participants With Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma Not yet recruiting USA 0
NCT05172700 Expanded access Pirtobrutinib Expanded Access Program for Pirtobrutinib for Participants With B-Cell Cancer Approved for marketing 0
NCT06812715 Phase II Pirtobrutinib Clonal Dynamics of Chronic Lymphocytic Leukaemia Treated with Pirtobrutinib After Previous Treatment with Zanubrutinib (PIPOZA) Recruiting AUS 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 | ROU | POL | NZL | ITA | HUN | GBR | FRA | ESP | CZE | BRA | BGR | AUT | AUS 6
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 | GBR | FRA | ESP | DNK | DEU | CZE | CHE | CAN | BRA | BEL | 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
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
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 | TUR | POL | NZL | ITA | ISR | HUN | GBR | FRA | ESP | DEU | CZE | CAN | BRA | BEL | AUT | AUS | ARG 5
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
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
NCT06333262 Phase II Obinutuzumab + Pirtobrutinib Pirtobrutinib Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia Active, not recruiting USA 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) Withdrawn 0
NCT07207785 Phase II Pirtobrutinib PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma (FIL_PUMA) Not yet recruiting ITA 0


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