Also known as: Brukinsa, Velexbru
Zanubrutinib is marketed as BRUKINSA, an oral kinase inhibitor for several adult B-cell malignancies, including CLL/SLL, Waldenstrom macroglobulinemia, mantle cell lymphoma, marginal zone lymphoma, and follicular lymphoma in specific prior-treatment settings. Initial U.S. approval was in 2019, with additional indications added subsequently.
Experts discuss balancing efficacy and safety in BTK inhibitor plus venetoclax combination therapy for CLL, including BTK lead-in strategies to reduce tumor lysis syndrome risk and the benefits of all-oral fixed-duration regimens.
The FDA has approved Bristol Myers Squibb's CAR-T therapy Breyanzi for relapsed/refractory marginal zone lymphoma, while a novel multiple myeloma drug candidate DTP3 advances to Phase 2 trials after showing promising early results. Both developments represent significant progress in blood cancer treatment, with the marginal zone lymphoma approval based on a 95.5% response rate and the myeloma drug demonstrating selective cancer cell killing without toxicity.
Global orphan drug sales are forecast to reach $409 billion by 2032, representing one-fifth of prescription drug sales, with Johnson & Johnson and Argenx leading the market amid regulatory uncertainty.
Recent studies demonstrate zanubrutinib delivers higher response rates, longer treatment persistence, and lower healthcare costs compared to acalabrutinib and ibrutinib across multiple B-cell malignancies, with particularly strong benefits in high-risk populations.
The FDA accepted a new drug application for tirabrutinib to treat relapsed or refractory primary central nervous system lymphoma, with a decision expected December 18, 2026. The application is supported by phase 2 trial data showing a 67% overall response rate.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration BTK inhibitor regimen for CLL/SLL and cleared monthly dosing for amivantamab in EGFR-mutated NSCLC. Additional regulatory reviews are underway for PCNSL and breast cancer treatments.
The FDA has accepted a new drug application for tirabrutinib, a BTK inhibitor, for relapsed/refractory primary central nervous system lymphoma under the accelerated approval pathway. The regulatory agency set a PDUFA target action date of December 18, 2026.
The FDA has accepted for filing the New Drug Application for tirabrutinib under the accelerated approval pathway for relapsed or refractory primary central nervous system lymphoma, setting a PDUFA action date of December 18, 2026.
Retrospective analysis of the ZUMA-2 trial found that previous ibrutinib exposure was associated with improved progression-free survival after brexucabtagene autoleucel treatment in mantle cell lymphoma patients, though with increased toxicity.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07594899 |
AI-Driven Treatment Strategy vs Pola-R-CHP in Untreated LBCL |
NOT_YET_RECRUITING | PHASE2 |
| NCT07377578 |
A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell Lymphoma |
RECRUITING | PHASE3 |
| NCT07341191 |
Sonrotoclax Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma Planned for Standard of Care CAR-T Cell Therapy |
RECRUITING | PHASE2 |
| NCT07321652 |
Testing the Addition of Anti-Cancer Drug Sonrotoclax, to the Standard Treatment Zanubrutinib, for Previously Untreated CLL/SLL |
NOT_YET_RECRUITING | PHASE3 |
| NCT07283965 |
Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies |
NOT_YET_RECRUITING | |
| NCT07277231 |
A Study to Investigate Sonrotoclax (BGB-11417) Plus Zanubrutinib (BGB-3111) Compared With Venetoclax Plus Acalabrutinib in Adults With Previously Untreated Chronic Lymphocytic Leukemia |
RECRUITING | PHASE3 |
| NCT07271667 |
A Study of Emavusertib + An Approved Bruton Tyrosine Kinase Inhibitor (BTKi) in Participants With Chronic Lymphocytic Leukemia (CLL) and Other B-cell Malignancies |
RECRUITING | PHASE2 |
| NCT07270835 |
Zanubrutinib Combined With Rituximab in the Treatment of Secondary HLH in B-cell Lymphoma |
RECRUITING | PHASE4 |
| NCT07261163 |
Obinutuzumab, Zanubrutinib, and Lenalidomide in First-line Treatment of Mantle Cell Lymphoma |
RECRUITING | PHASE2 |
| NCT07233720 |
Zanubrutinib Combined With Rituximab in the Treatment for Patients With Marginal Zone Lymphoma |
RECRUITING |
