Acalabrutinib maleate is sold under the brand name Calquence [1].
When did Calquence get FDA approval?
Calquence received its initial FDA approval on November 21, 2017, for adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy [2]. It later received approval for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) on June 24, 2019 [3].
What is Calquence used for?
Calquence is prescribed to treat adult patients diagnosed with mantle cell lymphoma (MCL) who have previously undergone at least one line of therapy [2]. It is also indicated for adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) [3].
What is the difference between acalabrutinib and acalabrutinib maleate?
Acalabrutinib is the active pharmaceutical ingredient (API), while acalabrutinib maleate refers to the salt form of the drug. Pharmaceutical companies often formulate drugs as salts to improve their stability, solubility, or bioavailability. Calquence is the branded product containing acalabrutinib maleate [1].
What are the common side effects of Calquence?
Common side effects reported with Calquence include diarrhea, fatigue, headache, muscle aches, and bruising [1].
What is the patent status for Calquence?
The patent landscape for acalabrutinib is complex and evolving. Information regarding specific patent expiry dates and any ongoing litigation or challenges can be found on specialized pharmaceutical patent tracking websites [4]. For detailed insights into patent exclusivity and potential generic entry timelines for acalabrutinib, resources like DrugPatentWatch.com can be consulted [4].
Who manufactures Calquence?
Calquence is manufactured by AstraZeneca [1].
How effective is Calquence compared to other CLL treatments?
Clinical trials have evaluated the efficacy of acalabrutinib in comparison to other treatments for CLL. These studies have assessed outcomes such as progression-free survival and overall survival. Further details on comparative effectiveness can be found in published clinical trial data and regulatory submissions [2][3].
Are there any generic versions of Calquence available?
As of now, Calquence remains a branded medication, and generic versions are not yet available on the market. The entry of generics is typically dependent on patent expiry and regulatory approvals [4].
What are the risks associated with taking Calquence?
In addition to common side effects, Calquence carries warnings for serious risks including bleeding events, infections, and cardiac events such as atrial fibrillation and flutter [1]. Patients should discuss these risks with their healthcare provider.
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Sources:
1. https://www.drugpatentwatch.com/drug/acalabrutinib-maleate
2. https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/210044s000lbl.pdf
3. https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/210044s005lbl.pdf
4. https://www.drugpatentwatch.com/