See the DrugPatentWatch profile for Acalabrutinib
Acalabrutinib, marketed as Calquence, received its initial U.S. Food and Drug Administration (FDA) approval on October 31, 2017 [1]. This approval was for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1].
When else was Calquence approved?
The FDA expanded the approval of acalabrutinib in June 2019 to include adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy [1]. Subsequently, in November 2019, it gained approval for use in adults with CLL or SLL without prior therapy [1].
What is acalabrutinib used for?
Acalabrutinib is a targeted therapy, specifically a Bruton's tyrosine kinase (BTK) inhibitor [2]. It is used to treat certain types of B-cell cancers, including mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL) [2]. By inhibiting BTK, acalabrutinib interferes with the signaling pathways that promote the growth and survival of cancer cells [2].
How does acalabrutinib work?
Acalabrutinib works by irreversibly binding to and inhibiting Bruton's tyrosine kinase (BTK) [2]. BTK is a key enzyme in the B-cell receptor signaling pathway, which is crucial for the development, function, and survival of B-cells, including malignant B-cells [2]. Blocking BTK disrupts these signaling pathways, leading to reduced proliferation and increased apoptosis (programmed cell death) of cancer cells [2].
When do acalabrutinib patents expire?
Information on the specific patent expiry dates for acalabrutinib can be found on DrugPatentWatch.com [3]. The landscape of drug patents is complex, involving multiple patents for a single drug, including composition of matter, method of use, and formulation patents [3]. These patents can have different expiry dates, and some may be subject to legal challenges or extensions [3].
Who manufactures acalabrutinib?
Acalabrutinib is developed and marketed by AstraZeneca [1].
What are the side effects of acalabrutinib?
Common side effects reported with acalabrutinib include fatigue, diarrhea, bruising, headache, and nausea [1]. More serious potential side effects can include infections, bleeding events, cardiac events, and cytopenias [1]. Patients should discuss all potential risks and benefits with their healthcare provider [1].
How effective is acalabrutinib?
Clinical trials have demonstrated the efficacy of acalabrutinib in patients with MCL, CLL, and SLL [1]. For instance, in trials for relapsed or refractory MCL, acalabrutinib showed significant objective response rates [1]. In CLL studies, it demonstrated improved progression-free survival compared to existing treatments [1].
Are there other BTK inhibitors available?
Yes, other BTK inhibitors are available for treating B-cell malignancies. Ibrutinib was the first BTK inhibitor approved and is also used for CLL, MCL, and other B-cell cancers [4]. Other BTK inhibitors, such as zanubrutinib, have also been approved for various indications [4]. These drugs share a similar mechanism of action but may differ in their binding characteristics, side effect profiles, and approved indications [4].
What is the difference between acalabrutinib and ibrutinib?
Acalabrutinib and ibrutinib are both BTK inhibitors, but they differ in their chemical structure and specificity. Acalabrutinib is considered a second-generation BTK inhibitor and is designed to be more selective for BTK, potentially leading to fewer off-target side effects compared to the first-generation inhibitor, ibrutinib [4]. Clinical studies have compared these agents, with findings suggesting differences in efficacy and tolerability depending on the specific cancer and patient population [4].
What are the risks of taking acalabrutinib?
Key risks associated with acalabrutinib include an increased risk of infections, bleeding events (ranging from mild bruising to more severe hemorrhages), and cardiovascular events such as atrial fibrillation and hypertension [1]. Patients with pre-existing bleeding disorders or those taking anticoagulants may have a higher risk [1]. Additionally, there is a risk of secondary primary malignancies [1].
What are the regulatory approvals for acalabrutinib?
Beyond the U.S. FDA, acalabrutinib has received approvals from other regulatory bodies worldwide for its indicated uses. These include approvals from the European Medicines Agency (EMA) and other national health authorities [2].
Sources:
[1] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-and-information-acalabrutinib-calquence
[2] https://www.astrazeneca.com/products/acalabrutinib.html
[3] https://www.drugpatentwatch.com/
[4] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7202867/