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.
Several drugmakers saw shares fall after earnings missed expectations. Alnylam's Amvuttra sales disappointed despite growth; Neurocrine's guidance underwhelmed; AbbVie's Imbruvica and Roche's Vabysmo fell short of consensus.
Six-year SEQUOIA trial data show zanubrutinib sustains a progression-free survival advantage (74% vs 32%) over bendamustine-rituximab in CLL without del(17p). Benefit extends to high-risk del(17p) patients.
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.
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.
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.
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.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07739459 |
Study of Zanubrutinib in Older Patients With Previously Untreated Chronic Lymphocytic Leukemia (CLL) |
NOT_YET_RECRUITING | PHASE2 |
| NCT07734038 |
Venetoclax Plus Zanubrutinib for the Treatment of Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma |
NOT_YET_RECRUITING | PHASE2 |
| NCT07717177 |
AI-Driven Treatment Strategy vs ZR2 in Older Treatment-naive Patients With LBCL |
NOT_YET_RECRUITING | PHASE2 |
| NCT07690761 |
Rituximab+ Zanubrutinib for Patients With Hairy Cell Leukemia and Hairy Cell Variant |
ENROLLING_BY_INVITATION | PHASE2 |
| NCT07674810 |
A Phase 2 Trial Of The Combination Of Zanubrutinib, Sonrotoclax, And Obinutuzumab For Patients With Treatment-Naïve Chronic Lymphocytic Leukemia |
NOT_YET_RECRUITING | PHASE2 |
| NCT07638722 |
Testing Mosunetuzumab Alone, With Zanubrutinib, or With Polatuzumab Vedotin for Treating Marginal Zone Lymphoma That Came Back or Didn't Get Better With Treatment |
NOT_YET_RECRUITING | PHASE2 |
| 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 |
RECRUITING | PHASE3 |
