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Zanubrutinib

Zanubrutinib

Drug

Also known as: Brukinsa, Velexbru

Drug Profile

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.

Drug Class: Kinase inhibitor (BTK inhibitor)
Approval Status: FDA approved (Initial U.S. Approval: 2019; some lymphoma indications remain accelerated approvals)
Mechanism of Action: Kinase-inhibitor mechanism used in B-cell malignancies (BTK-targeted class).

Brand Names

BRUKINSA

Indications

\Chronic lymphocytic leukemia or small lymphocytic lymphoma\
\Waldenstrom macroglobulinemia\
\Relapsed/refractory mantle cell lymphoma after at least one prior therapy\
\Relapsed/refractory marginal zone lymphoma after at least one anti-CD20-based regimen\
\Relapsed/refractory follicular lymphoma in combination with obinutuzumab after two or more lines of systemic therapy\

Related News

FDA Accepts Deciphera's NDA for Tirabrutinib in Relapsed/Refractory PCNSL

Jun 15, 2026

The U.S. FDA has accepted for filing a 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. The submission is supported by Phase 2 PROSPECT study results showing a 67% overall response rate and 44% complete response rate. If approved, tirabrutinib would be the first BTK inhibitor commercially available in the U.S. for this indication.

Chinese Biotech Exports Surge to $137.7B as U.S. Drugmakers Rush to Acquire Chinese Candidates

Jun 10, 2026

China's biotech overseas technology transfer agreements reached $137.7 billion in 2025, nearly ten times the 2021 figure, as global drugmakers rush to acquire Chinese candidates. BeiGene's Brukinsa surpassed $4 billion in global sales, while Pfizer agreed to a deal with Innovent Biologics worth up to $10.5 billion. U.S. lawmakers are raising security concerns about growing dependence on Chinese biotech.

Oncology Pipeline Update: Prostate Cancer T-Cell Engager Partnership, BTK Inhibitor Filing, and Novel Targeted Therapy Results

Jun 05, 2026

Key oncology developments include a $315 million partnership between Astellas and Vir for the prostate cancer T-cell engager VIR-5500, with updated phase 1 data showing an 82% PSA50 rate. The FDA accepted a filing for Ono Pharmaceuticals' tirabrutinib seeking accelerated approval in primary central nervous system lymphoma. Research findings also identified a new kidney cancer biomarker and showed promising results for the TRK inhibitor repotrectinib and the breast cancer triple therapy gedatolisib plus palbociclib and fulvestrant.

BTKi Plus BCL-2i Combination Therapy in CLL: Safety, Lead-In Strategies, and Patient Counseling

Apr 29, 2026

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.

FDA Approves CAR-T Therapy for Marginal Zone Lymphoma, New Myeloma Drug Advances to Phase 2

Mar 24, 2026

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.

Orphan Drug Market Projected to Reach $409 Billion by 2032, Driven by Rare Disease Treatments

Mar 17, 2026

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.

Zanubrutinib Shows Superior Efficacy and Persistence Over Other BTK Inhibitors in CLL and B-Cell Lymphomas

Mar 11, 2026

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.

FDA Accepts Tirabrutinib Application for Relapsed Primary CNS Lymphoma

Feb 24, 2026

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.

FDA Approves First-Line Acalabrutinib Regimen for CLL/SLL, Expands NSCLC Dosing Options

Feb 21, 2026

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.

FDA Accepts Tirabrutinib NDA for Relapsed/Refractory PCNSL, Sets December 2026 Action Date

Feb 18, 2026

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.

Related Clinical Trials

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