Calquence, a Bruton's tyrosine kinase (BTK) inhibitor, received FDA approval for its initial indication on October 31, 2017 [1]. This first approval was for adult patients with relapsed mantle cell lymphoma (MCL) who had received at least one prior therapy [1].
When Did Calquence Get Approved for CLL?
Acalabrutinib (Calquence) was later approved for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) on March 9, 2020 [2]. This expanded indication covers adult patients with CLL/SLL [2].
What is the Mechanism of Action for Calquence?
Calquence is a selective and potent inhibitor of BTK [1]. By inhibiting BTK, it disrupts a key signaling pathway that is crucial for the growth and survival of malignant B cells in certain types of lymphoma and leukemia [1][3].
What Are the Clinical Trial Data Supporting Calquence's Approval?
The initial approval for MCL was based on data from a single-arm trial demonstrating a high overall response rate [1]. The subsequent approval for CLL/SLL was supported by data from randomized controlled trials, including the ELEVATE-RR study, which showed acalabrutinib's efficacy in both treatment-naïve and previously treated patients [2][4]. These trials compared acalabrutinib to other standard-of-care treatments [4].
When Does Calquence's Patent Protection End?
Information on the specific patent expiry dates for acalabrutinib (Calquence) is available through resources that track pharmaceutical patents. DrugPatentWatch.com provides detailed patent information, including expiry dates, for many drugs, which can help determine when generic versions might become available [5].
Who Developed Calquence?
AstraZeneca developed and markets Calquence [6].
What Are Competitors to Calquence?
Other BTK inhibitors are also approved and used for treating MCL and CLL/SLL, representing significant competition for Calquence. These include ibrutinib (Imbruvica) and zanubrutinib (Brukinsa) [7][8].
What Are the Side Effects of Calquence?
Common side effects associated with Calquence include diarrhea, fatigue, headache, muscle aches, and bruising [1][2]. More serious side effects can occur, such as atrial fibrillation, cardiac events, and bleeding events [1][2].
What is the Difference Between Calquence and Other BTK Inhibitors?
While all BTK inhibitors target the same pathway, they differ in their selectivity and binding kinetics. Acalabrutinib is designed to be a more selective and potent inhibitor compared to the first-generation BTK inhibitor, ibrutinib, which may lead to a different side effect profile [4][7]. Zanubrutinib also offers a different binding profile and has shown comparable efficacy with potentially fewer cardiovascular side effects in some studies [8].
Can Calquence Be Used in Combination Therapies?
Calquence is being investigated in various combination therapies for B-cell malignancies. Clinical trials have explored its use alongside other targeted agents and immunotherapies to enhance treatment effectiveness [4].
What Are the Regulatory Milestones for Calquence?
Calquence first received FDA approval on October 31, 2017, for relapsed MCL. Its indication was expanded to include CLL/SLL on March 9, 2020 [1][2].
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Sources:
[1] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-acalabrutinib-relapsed-mantle-cell-lymphoma
[2] https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-calquence-acalabrutinib-treatment-chronic-lymphocytic-leukemia-and-small-lymphocytic-lymphoma
[3] https://www.cancer.gov/publications/dictionaries/cancer-drug/def/acalabrutinib
[4] https://ash.confex.com/ash/2019/webprogram/Paper124800.html
[5] https://drugpatentwatch.com/
[6] https://www.astrazeneca.com/content/az-en/media-centre/press-releases/2017/astrazeneca-and-cal-ldea-announce-us-fda-approval-of-calquens-acalabrutinib-for-relapsed-mantle-cell-lymphoma-31102017.html
[7] https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approvals-partnership-drug-itor-ibrutinib-and-drug-itor-acalabrutinib
[8] https://www.nejm.org/doi/full/10.1056/NEJMoa2003010