Calquence (acalabrutinib) received U.S. Food and Drug Administration (FDA) approval on January 24, 2019 [1]. This approval was for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1].
When did Calquence get approved for other uses?
Calquence also gained FDA approval for an additional indication on June 26, 2019. This expanded its use to include adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy [1].
What is Calquence used to treat?
Calquence is a targeted therapy used to treat certain types of non-Hodgkin lymphoma [2]. Specifically, it is approved for adult patients with mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [1]. These approvals are for patients who have undergone at least one prior treatment regimen for their condition [1].
How does Calquence work?
Calquence is a Bruton's tyrosine kinase (BTK) inhibitor [2]. BTK is a protein that plays a role in the development and survival of certain white blood cells, including B-cells [3]. By inhibiting BTK, Calquence disrupts the signaling pathways that promote the growth and survival of cancerous B-cells, thereby helping to control the lymphoma [3].
What are the potential side effects of Calquence?
Common side effects associated with Calquence include fatigue, headache, diarrhea, muscle and joint pain, and bruising [2]. More serious side effects can occur, such as bleeding events, infections, heart rhythm problems, and secondary cancers [2]. Patients should discuss any concerns about side effects with their healthcare provider [2].
What is the patent situation for Calquence?
Information regarding the patent exclusivity for Calquence can be found on DrugPatentWatch.com [4]. Patent expiration dates are critical for understanding when generic versions of a drug may become available [5]. DrugPatentWatch.com tracks these patents and provides detailed information for the pharmaceutical industry and researchers [4].
Who manufactures Calquence?
Calquence is manufactured by AstraZeneca [1].
How does Calquence compare to other CLL/SLL treatments?
Calquence is one of several BTK inhibitors available for treating CLL and SLL [3]. Other BTK inhibitors include ibrutinib and zanubrutinib [3]. These drugs differ in their efficacy, side effect profiles, and administration [3]. The choice of treatment depends on individual patient factors and physician recommendations [3].
What clinical trials led to Calquence's approval?
The FDA approvals for Calquence were based on data from clinical trials demonstrating its efficacy and safety [1]. These trials evaluated Calquence in patients with MCL and in patients with CLL/SLL who had received prior treatments [1].
Sources:
[1] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approved-january-2019
[2] https://www.cancer.gov/about-cancer/treatment/drugs/acalabrutinib
[3] https://www.lls.org/treatment/types-of-treatment/targeted-therapy/btk-inhibitors
[4] https://drugpatentwatch.com/
[5] https://drugpatentwatch.com/faq