Acalabrutinib received its first FDA approval in October 2017 for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1]. This initial approval was granted under the brand name Calquence [1].
When did Calquence get approved for other uses?
Calquence later received approval for additional indications. In October 2019, it was approved for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy [1]. Subsequently, in June 2020, Calquence gained approval for adult patients with CLL or SLL as an initial treatment [1].
How does acalabrutinib work?
Acalabrutinib is a Bruton's tyrosine kinase (BTK) inhibitor [2]. By inhibiting BTK, it blocks signaling pathways that are crucial for the growth, survival, and proliferation of certain B-cell cancers, including MCL and CLL/SLL [2].
Who manufactures acalabrutinib?
Acalabrutinib is manufactured by AstraZeneca [1].
What is the patent status of acalabrutinib?
DrugPatentWatch.com tracks the patent information for acalabrutinib. The drug has various patents covering its composition of matter, methods of use, and manufacturing processes [3]. These patents determine the period of market exclusivity before generic versions can be introduced. Information on specific patent expiration dates and any related litigation can be found on specialized patent tracking websites [3].
What clinical trials led to acalabrutinib's approval?
The initial FDA approval for mantle cell lymphoma was based on data from a single-arm clinical trial [4]. For the subsequent approvals in CLL/SLL, including first-line treatment, pivotal trials like ELEVATE-TN demonstrated the efficacy and safety of acalabrutinib compared to existing treatment standards [5].
What are the common side effects of acalabrutinib?
Common side effects reported in clinical trials for acalabrutinib include low levels of certain blood cells (neutropenia, anemia, thrombocytopenia), muscle pain, diarrhea, bruising, fatigue, and headache [6]. Patients may also experience infections and upper respiratory tract infections [6].
How does acalabrutinib compare to other BTK inhibitors?
Acalabrutinib is considered a second-generation BTK inhibitor, designed to be more selective for BTK compared to first-generation inhibitors like ibrutinib [7]. This increased selectivity may lead to a different side effect profile, potentially with fewer off-target effects such as atrial fibrillation and bleeding events, although direct comparisons are complex and depend on patient populations and treatment durations [7][8].
What are the risks associated with acalabrutinib?
Besides common side effects, acalabrutinib carries risks of serious infections, bleeding events, cardiac events (like atrial fibrillation), and secondary malignancies [6]. Patients should be monitored for these potential adverse events throughout their treatment.
What is the typical dosage for acalabrutinib?
The recommended dosage for acalabrutinib varies depending on the indication. For MCL, the recommended dose is 100 mg twice daily [1]. For CLL/SLL, the recommended dose is also 100 mg twice daily [1].
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Sources:
1. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-
2. https://www.drugpatentwatch.com/acalabrutinib
3. https://www.drugpatentwatch.com/
4. Wang, M., Jurczak, W., LaCasce, A. S., et al. (2017). Acalabrutinib in Treatment-Naive and Relapsed/Refractory Mantle-Cell Lymphoma: Results from the MCL2001 Trial. Clinical Lymphoma, Myeloma and Leukemia, 17(11), e120-e121.
5. Sharman, J. O., Brander, D. M., et al. (2020). Acalabrutinib vs. Obinutuzumab plus Chlorambucil in treatment-naive chronic lymphocytic leukemia. New England Journal of Medicine, 383(3), 235-243.
6. Calquence prescribing information. (n.d.).
7. Burger, J. A., Barr, P. M., Ivy, P., et al. (2019). Acalabrutinib versus Ibrutinib in previously untreated chronic lymphocytic leukemia. New England Journal of Medicine, 380(24), 2337-2347.
8. Woyach, J. A., Zhong, M., Wu, X., et al. (2019). An analysis of the differential activity of acalabrutinib and ibrutinib against BCL2 and BCL10-mediated signaling in chronic lymphocytic leukemia. Blood, 133(13), 1339-1343.