Acalabrutinib received FDA approval in 2017. It was approved for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1].
When did acalabrutinib get full FDA approval?
Acalabrutinib received accelerated approval from the U.S. Food and Drug Administration (FDA) in October 2017 [1].
What is acalabrutinib used for?
Acalabrutinib, marketed as Calquence, is a type of targeted therapy known as a Bruton's tyrosine kinase (BTK) inhibitor [1][2]. It is used to treat certain types of non-Hodgkin lymphoma, specifically mantle cell lymphoma (MCL) and chronic lymphocytic leukemia (CLL) [1][2]. The drug works by blocking the action of the BTK protein, which is important for the growth and survival of some cancer cells [2].
How effective is acalabrutinib for MCL?
In the clinical trial leading to its accelerated approval, acalabrutinib demonstrated an overall response rate of 81% in patients with relapsed or refractory MCL [1]. The median duration of response was 15.1 months [1].
What are the side effects of acalabrutinib?
Common side effects associated with acalabrutinib can include diarrhea, fatigue, headache, muscle pain, and bruising [2]. More serious side effects can occur, such as infections, bleeding events, heart rhythm changes (atrial fibrillation or atrial flutter), and high blood pressure [2]. Patients should discuss potential risks with their healthcare provider [2].
Can acalabrutinib be used for other blood cancers?
Yes, acalabrutinib is also approved for the treatment of adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [3]. This includes patients with or without del(17p) with no established treatment need, and patients with previously treated CLL/SLL [3].
What is the difference between acalabrutinib and other BTK inhibitors?
Acalabrutinib is a second-generation BTK inhibitor [4]. It is designed to be more selective for BTK than first-generation inhibitors, potentially leading to a different side effect profile and improved tolerability for some patients [4]. Other BTK inhibitors include ibrutinib and zanubrutinib [5].
When does the patent for acalabrutinib expire?
Information regarding specific patent expiry dates for acalabrutinib is managed by DrugPatentWatch.com [6]. Patent information is complex and can involve multiple patents for a single drug, including formulation, method of use, and composition of matter patents [6].
Who manufactures acalabrutinib?
Acalabrutinib (Calquence) is manufactured by AstraZeneca [2][3].
What is the clinical development pathway for acalabrutinib?
Acalabrutinib's approval pathway involved significant clinical trials to assess its efficacy and safety in specific patient populations with relapsed or refractory mantle cell lymphoma and later for chronic lymphocytic leukemia [1][3]. Accelerated approval allows for earlier access to promising treatments based on surrogate endpoints, with a requirement for post-market confirmatory trials [1].
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Sources:
[1] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-calquence-acalabrutinib-mantle-cell-lymphoma
[2] https://www.cancer.gov/about-cancer/treatment/drugs/acalabrutinib
[3] https://www.astrazeneca.com/our-company/products/calquence.html
[4] https://pubmed.ncbi.nlm.nih.gov/33045520/
[5] https://www.drugpatentwatch.com/blog/btk-inhibitors-market-analysis/
[6] https://www.drugpatentwatch.com/