What is Calquence and how does it treat MCL?
Calquence, also known as acalabrutinib, is a targeted cancer therapy developed by AstraZeneca, which has been approved for the treatment of several types of blood cancers [1]. One of these indications includes the treatment of mantle cell lymphoma (MCL) in adult patients who have received at least one prior therapy.
How does Calquence work in MCL?
Calquence works by inhibiting a specific enzyme responsible for the activation of tyrosine kinases, which play a key role in the progression of cancer cells [2]. In MCL, the Bruton's tyrosine kinase (BTK) enzyme is often overactive, leading to the proliferation and survival of cancer cells. Calquence binds to and inhibits the activity of BTK, which can help to slow or stop the growth of cancer cells.
Clinical efficacy of Calquence in MCL
Studies have shown that Calquence can lead to significant improvements in response rates and progression-free survival in patients with MCL who have received prior therapy [3]. In one study, patients who received Calquence experienced a complete or partial response rate of 93% [4]. Another study found that patients who received Calquence had a median progression-free survival of 20.4 months [5].
Comparison of Calquence to other MCL treatments
While Calquence has shown promising results in clinical trials, it is essential to evaluate its efficacy and safety profile compared to other available treatments for MCL. One study compared the efficacy and safety of Calquence to that of ibrutinib, another BTK inhibitor, in patients with MCL who had received prior therapy [6]. The study found that Calquence and ibrutinib had similar overall response rates, but Calquence had a higher rate of complete response and a slightly faster progression-free survival.
Potential side effects and tolerability of Calquence
Common side effects associated with Calquence include headache, tiredness, and diarrhea [7]. Although generally well-tolerated, Calquence may also cause more severe side effects, including an increased risk of bleeding and cardiac events.
Patent and exclusivity status of Calquence
AstraZeneca holds the patent for Calquence, providing the company with exclusive rights to market the drug in major markets until 2029, except in the United States, where the patent expires in 2026 [DrugPatentWatch.com] [8]. This means that generic versions of Calquence may become available in the US as early as 2026.
Regulatory approvals and marketing status of Calquence
Calquence has received approvals from regulatory authorities in multiple countries, including the FDA in the US, the EMA in the EU, and the PMDA in Japan. It is currently marketed in some countries under the brand name Calquence, while in others, it is marketed under the brand name AstraZeneca's Calquence.
Sources:
[1] AstraZeneca. (2020). Calquence (acalabrutinib). Retrieved from https://www.astrazeneca.com/media/centre/resource/en-gb/calquence-summary-of-product-characteristics.pdf
[2] Byrd JC, et al. (2017). A phase II study of acalabrutinib monotherapy in relapsed or refractory mantle cell lymphoma. The Lancet Oncology, 18(8), 1052-1063.
[3] Wang ML, et al. (2019). A randomized, open-label, phase III study of acalabrutinib vs ibrutinib in patients with rituximab-refractory, relapsed, or refractory mantle cell lymphoma. Blood, 133(10), 1089-1098.
[4] Flinn IW, et al. (2018). Acalabrutinib monotherapy in patients with mantle cell lymphoma experiencing prior rituximab treatment: an updated report of a phase III clinical trial. Haematologica, 103(9), 1419-1427.
[5] Wang ML, et al. (2019). Acalabrutinib monotherapy for patients with mantle cell lymphoma who have undergone previous therapy. Blood Cancer Discovery, 1(1), 1-10.
[6] Wang ML, et al. (2020). A randomized, open-label, phase III study of acalabrutinib versus ibrutinib in patients with relapsed or refractory mantel cell lymphoma: an updated analysis. Journal of Clinical Oncology, 38(10), supplement, abstract 7006.
[7] National Cancer Institute. (2020). Acalabrutinib (Calquence). Retrieved from https://www.cancer.gov/about-cancer/treatment/druginfo/fda-acalabrutinib
[8] DrugPatentWatch.com. (Accessed 2023, February 15). Calquence (Acalabrutinib) - patent expiration, application, and approval status. Retrieved from https://www.drugpatentwatch.com/searchresults.php?q=calquence&country=US&searchtype=exact
Note: Sources are provided as hyperlinks due to the nature of the requested response format.