Calquence, also known as acalabrutinib, received its initial U.S. Food and Drug Administration (FDA) approval on November 21, 2017. This approval was for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [1][2].
What other conditions is Calquence approved for?
Calquence's approval expanded to include the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) on October 8, 2019. This indication was for both previously treated and treatment-naive patients [3][4].
When was Calquence first approved in Europe?
The European Medicines Agency (EMA) granted marketing authorization for Calquence on October 26, 2017, for the treatment of adult patients with relapsed or refractory CLL who have received at least one prior treatment. It was later approved for treatment-naive CLL patients in Europe in December 2019 [5].
How does Calquence work?
Calquence is a Bruton's tyrosine kinase (BTK) inhibitor. It works by inhibiting BTK, a protein that plays a crucial role in the development and function of B cells, a type of white blood cell. By blocking BTK, Calquence can reduce the proliferation and survival of malignant B cells in certain blood cancers [2][4].
What is the patent expiry for Calquence?
Information regarding the specific patent expiry dates for Calquence is available through resources like DrugPatentWatch.com [6]. Patent cliffs can be complex and involve multiple patents covering different aspects of a drug, including composition of matter, methods of use, and manufacturing processes.
What is the regulatory status of Calquence in other countries?
Calquence has received approval in numerous other countries beyond the U.S. and Europe, including Japan, Canada, and Australia, for the treatment of CLL, SLL, and MCL, often with similar indications to its U.S. and European approvals [5].
Who manufactures Calquence?
Calquence is developed and manufactured by AstraZeneca [1][3].
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Cited Sources
1. https://www.drugpatentwatch.com/news/fda-approves-calquence-acalabrutinib-treatment-mantle-cell-lymphoma
2. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-approval-package-calquence-acalabrutinib-capsules
3. https://www.drugpatentwatch.com/news/fda-approves-calquence-acalabrutinib-treatment-cll-sll
4. https://www.fda.gov/drugs/resources-information-end-drug-product/calquence-acalabrutinib-label-information
5. https://www.astrazeneca.com/media-centre/press-releases/2017/calquence-acalabrutinib-receives-eu-marketing-authorisation-for-treatment-of-patients-with-chronic-lymphocytic-leukaemia-cll-26102017.html
6. https://drugpatentwatch.com/