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Calquence Approved for Mantle Cell Lymphoma

FDA news release; 2017 Oct 31

Publish date:: November 8, 2017

The FDA has granted accelerated approval to Calquence (acalabrutinib) for the treatment of certain adults with mantle cell lymphoma (MCL).

Indications: Calquence is a kinase inhibitor indicated for the treatment of adult patients with MCL who have received at least 1 prior therapy.

Dosage and administration: Recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water.

Efficacy and safety: Approval is based on a trial involving 124 individuals showing 8 in every 10 who took Calquence achieved a complete or partial response.

Side effects/risks: The most common adverse reactions are anemia, thrombocytopenia, headache, neutropenia, diarrhea, fatigue, myalgia, and bruising.

Citation:

FDA approves new treatment for adults with mantle cell lymphoma. [news release]. Silver Spring, MD: FDA. October 31, 2017. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm583076.htm. Accessed November 6, 2017.

Calquence [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP. 2017. https://www.azpicentral.com/calquence/calquence.pdf. Accessed November 6, 2017.

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