Treats previously untreated mantle cell lymphoma (MCL). Sold as Calquence. Every FDA application for this active ingredient: 1 branded and 2 generic.
As of Nov 15, 2026, FDA lists 3 applications for Acalabrutinib (sold as Calquence), first approved Oct 31, 2017, with 4 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Calquence | Part D | $2.51B | +48% | 21,731 |
| MACE and BTK InhibitorsHematologic Cancer, MACE · University Hospital, Caen | Phase 4 | Not yet recruiting | Nov 6, 2026 |
| Polatuzumab Vedotin, Mosunetuzumab, and Acalabrutinib for the Treatment of Mantle Cell Lymphoma, PAcMan TrialMantle Cell Lymphoma · University of Washington | Phase 2 | Not yet recruiting | Nov 2, 2026 |
| Atrial Fibrillation Among Patients With Hematologic Malignancies on Tyrosine Kinase Inhibitor TherapyAtrial Fibrillation (AF), Chronic Lymphocytic Leukemia · Tina Baykaner | — | Not yet recruiting | Jul 17, 2026 |
| Acalabrutinib Maleate and Bortezomib for Patients With HLA AntibodiesHematological Malignancies, Platelet Transfusion Refractoriness (PTR) · The First Affiliated Hospital of Soochow University | Phase 3 | Not yet recruiting | Jun 9, 2026 |
| Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic LymphomaChronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma · City of Hope Medical Center | Phase 2 | Recruiting | May 12, 2026 |
| A Study of Rocbrutinib Versus Investigator's Choice of BTK Inhibitors in Patients With Relapsed or Refractory Mantle Cell LymphomaMantle Cell Lymphoma · Guangzhou Lupeng Pharmaceutical Company LTD. | Phase 3 | Recruiting | Jan 30, 2026 |
| Observ Prosp Study of Acalabrutinib in CLL Therapy in Real Clinical Practice in BelarusChronic Lymphocytic Leukemia · AstraZeneca | — | Recruiting | Dec 17, 2025 |
| Zanubrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell MalignanciesChronic B-cell Malignancies, BTK Inhibitors · University Hospital, Caen | — | Not yet recruiting | Dec 16, 2025 |
| Oct 31, 2017 | CalquenceNDA 210259 · New molecular entity | Astrazeneca | 6 | Marketed |
| — | AcalabrutinibANDA 216775 | Alembic Pharms Ltd | 0 | Discontinued |
| — | AcalabrutinibANDA 216833 | Msn Laboratories Private Ltd | 0 | Discontinued |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
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