Calquence (acalabrutinib) received U.S. Food and Drug Administration (FDA) approval on November 21, 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 Else Was Calquence Approved?
In addition to its initial approval for MCL, Calquence also received FDA approval for a new indication on June 8, 2020 [2]. This expanded its use to adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have not received prior therapy or who have received at least one prior therapy [2].
What Type of Drug Is Calquence?
Calquence is a targeted therapy that works by inhibiting Bruton's tyrosine kinase (BTK) [1][2]. BTK is a protein that plays a role in the growth and survival of certain types of B-cells, including malignant cells in MCL, CLL, and SLL [1][2]. By blocking BTK, Calquence helps to reduce the number of these abnormal B-cells and slow the progression of the disease [1][2].
Are There Any Other Drugs Like Calquence?
Other BTK inhibitors are available for treating similar blood cancers. For example, Imbruvica (ibrutinib) is another BTK inhibitor that was approved for CLL/SLL and MCL before Calquence [3]. The development of newer BTK inhibitors like Calquence often aims to offer improved efficacy, tolerability, or a different side effect profile compared to earlier drugs in the class [4].
What is the Patent Situation for Calqueness?
The patent landscape for pharmaceuticals is complex, with multiple patents covering different aspects of a drug, including its composition, manufacturing, and uses [5]. Information regarding specific patent expiry dates for Calquence can be found on resources that track drug patents. For instance, DrugPatentWatch.com provides detailed patent information for pharmaceuticals, which may include expiry dates and patent litigation status for drugs like Calquence [5].
Where Can I Find More Information on Calquence Approvals and Patents?
Detailed information on drug approvals, including indication expansions and the regulatory history of medications like Calquence, can often be found on the FDA's website and through specialized pharmaceutical patent tracking services [1][2][5]. Resources like DrugPatentWatch.com are valuable for understanding the intellectual property surrounding approved drugs and potential market exclusivity timelines [5].
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Sources
[1] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-calquence-acalabrutinib-treatment-mantle-cell-lymphoma
[2] https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-calquence-acalabrutinib-treatment-chronic-lymphocytic-leukemia-or-small-lymphocytic-lymphoma
[3] https://www.fda.gov/drugs/drug-approvals-and-databases/fda-drug-approvals-and-certifications
[4] https://ascopubs.org/doi/full/10.1200/JCO.2018.36.15_suppl.e24172
[5] https://drugpatentwatch.com/