Acalabrutinib is a targeted anti-cancer medicine marketed as Calquence for B-cell malignancies including mantle cell lymphoma and chronic lymphocytic leukemia/small lymphocytic lymphoma. It is a second-generation Bruton's tyrosine kinase inhibitor designed to block BTK signaling in malignant B cells. The FDA has granted approvals for mantle cell lymphoma indications, including a traditional approval update in 2025.
FDA approves Genentech's Tecentriq as first ctDNA-guided adjuvant therapy for muscle-invasive bladder cancer, and Venclexta plus acalabrutinib as first all-oral fixed-duration regimen for CLL.
AbbVie raised 2026 revenue and EPS guidance after first-quarter results beat estimates, with Skyrizi and Rinvoq driving growth. Humira erosion continued as neuroscience, oncology and pipeline assets supported the outlook.
AbbVie filed an sBLA for SKYRIZI as a subcutaneous induction therapy for Crohn's disease, supported by Phase 3 AFFIRM data. SKYRIZI and Rinvoq combined for $25.9B in 2025 revenue, exceeding 2027 guidance. The FDA also approved Venclexta plus acalabrutinib in CLL.
Ascentage Pharma said six clinical abstracts were selected for ASCO 2026 and four preclinical studies will be presented at AACR 2026. The presentations feature olverembatinib and other pipeline candidates.
The FDA approved acalabrutinib plus venetoclax for previously untreated CLL/SLL based on phase 3 AMPLIFY data. The fixed 14-month regimen improved progression-free survival versus chemotherapy.
The phase 3 AMPLIFY trial in frontline chronic lymphocytic leukemia showed improved efficacy with acalabrutinib plus venetoclax versus standard of care. The source text identified the study as NCT03836261.
AbbVie reported Q4 earnings that beat consensus estimates with $16.62 billion in revenue, while facing competitive setbacks in psoriatic arthritis and Medicare pricing challenges for Botox.
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.
AbbVie has successfully transitioned from Humira dependence to growth driven by Skyrizi and Rinvoq, while maintaining a 54-year dividend increase streak and expanding its pipeline to roughly 90 programs through strategic acquisitions.
The FDA approved acalabrutinib combined with venetoclax for chronic lymphocytic leukemia and small lymphocytic leukemia based on phase III trial results. Separately, Yale researchers identified CD25 protein complex as a new drug target for aggressive leukemias.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07582159 |
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma |
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 |
| 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 |
| NCT07257055 |
Phase 2 Study of BTKi-Rituximab Induction Followed by Glofitamab Consolidation in High Risk Untreated MCL Patients - WINDOW-4 Study |
RECRUITING | PHASE2 |
| NCT07052695 |
Mosunetuzumab for CLL MRD Clearance |
RECRUITING | PHASE1/PHASE2 |
| NCT07024706 |
Phase 2 Study of Disease Risk Mutation-Guided Finite Acalabrutinib+Venetoclax for Relapsed CLL Post-1L Finite cBTKi+BCL2i ± Obinutuzumab |
NOT_YET_RECRUITING | PHASE2 |
| NCT07014917 |
Intermittent Versus Continuous Venetoclax With Acalabrutinib for CLL/SLL |
RECRUITING | PHASE2 |
| NCT06846489 |
Acalabrutinib Plus Rituximab for the Treatment of Elderly or Low- to Intermediate-Risk Younger Untreated Mantle Cell Lymphoma |
RECRUITING | PHASE2 |
| NCT06839872 |
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 |
WITHDRAWN | PHASE2 |
