pirtobrutinib
pirtobrutinib: sourced relationships with 1 company · 25 clinical trials tracked · 1 FDA decision.
pirtobrutinib evidence translation
What we can confirm
1 FDA record · 25 tracked trials
What it means
What to watch
Prepared research question
How could pirtobrutinib → LOXO affect its developer, and what evidence supports the link?
Traceable citations · Unknowns marked
See linked entities and source evidence5 indications · 2 study sponsors
Dated Pipeline Records (2)
| Company | Dated record stage |
|---|---|
| LOXO ONCOLOGY, INC. (LOXO) Reported 2023-01-27 · Current development: unknownSource | Approved |
| LOXO ONCOLOGY, INC. (LOXO) Reported 2023-01-27 · Current development: unknownSource | Approved |
Clinical Trial Registry Records (25)showing 10 most recent
A Phase II Study of Mosunetuzumab in Combination With Pirtobrutinib in Patients With Relapsed or Refractory Waldenstrom Macroglobulinemia (MPOWER)
Primary endpoint: The recommended phase 2 dose (RP2D) which will be determined based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period.
A Randomized, Multicenter, Open-label, Phase 3 Study to Compare ICP-248 in Combination With Orelabrutinib Versus Pirtobrutinib in Participants With Relapsed or Refractory Mantle Cell Lymphoma (r/r MCL)
Primary endpoint: Progression-free survival (PFS) as assessed by Independent Review Committee (IRC).
A Randomized Phase III Study of Pirtobrutinib Plus R-CHOP vs. R-CHOP for Participants With Previously Untreated Richter Transformation (PIRAMID)
Primary endpoint: Progression free survival (PFS)
A Phase 3, Randomized, Open-label, Multicenter Study of NX-5948 Versus Pirtobrutinib in Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
Primary endpoint: Progression-free survival (PFS) as assessed by Independent Review Committee (IRC)
Long-Term Safety of Pirtobrutinib in Participants From Study LOXO-BTK-20020 With BTKi Pretreated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Primary endpoint: Percentage of Participants with a Grade 3 or Higher Treatment-emergent Adverse Events (AEs)
PROMOTE-FL: Pirtobrutinib and Mosunetuzumab to Enhance Treatment Efficacy for Patients With Relapsed/Refractory Follicular Lymphoma
Primary endpoint: Complete remission (CR) rate
A Phase II Study of Time-limited Combination of Pirtobrutinib, Venetoclax, and Rituximab in Treatment Naïve Patients With Waldenström's Macroglobulinemia (WM) / Lymphoplasmacytic Lymphoma (LPL) (PRoVen)
Primary endpoint: Number of participants with Very Good Partial Response Rate or Better
A Phase 3, Open-Label, Randomized Study to Evaluate the Safety and Efficacy of BGB-16673 Compared to Pirtobrutinib in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Primary endpoint: Progression-Free Survival (PFS) per Independent Review Committee (IRC)
Long-Term Safety of Pirtobrutinib in Participants From Study J2N-MC-JZNJ With Previously Treated Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma or Non-Hodgkin Lymphoma
Primary endpoint: Percentage of Participants with Grade 3 or Higher Treatment-emergent Adverse Events
A Phase 1/2, Dose-finding Study Investigating the Safety and Efficacy of Pirtobrutinib in Adults With Immune Thrombocytopenia
Primary endpoint: Phase 1-Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration
FDA Decisions1 records
Frequently asked questions
Which companies have sourced relationships with pirtobrutinib?
pirtobrutinib has dated SEC/FDA relationship records for LOXO ONCOLOGY, INC..
How many clinical trials involve pirtobrutinib?
BioSniper tracks 25 clinical trials involving pirtobrutinib.
What is pirtobrutinib's latest FDA decision?
The most recent tracked FDA decision for pirtobrutinib is Approval, dated January 27, 2023.