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FDA Approves Calquence for CLL and SLL

The drug acalabrutinib (Calquence®) was recently approved to treat 2 more types of blood cancer in adults: chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It had already been approved to treat mantle cell lymphoma, a rare form of non-Hodgkin lymphoma, in 2017. The U.S. Food & Drug Administration (FDA) announced this new approval in November 2019 under Project Orbis.1

What is Project Orbis?

Project Orbis is a new FDA project to review cancer drugs with international partners in Canada and Australia. By pooling data on safety and effectiveness, the FDA hopes to speed approvals of drugs for rare or under-served conditions like CLL and SLL.

The clinical trials used to study acalabrutinib included the Elevate-TN trial with 535 people and the Ascend trial with 310 people. In the Elevate-TN trial, doctors compared how well acalabrutinib worked to other standard treatments.1-2

In the Ascend trial, people with relapsed or refractory CLL who had already tried one other systemic drug treatment were given acalabrutinib, or other standard treatments. In both trials, participants showed longer progression-free survival, meaning their cancer did not get worse.

How does acalabrutinib (Calquence) work?

Acalabrutinib (Calquence) is a kinase inhibitor, a type of targeted therapy. Kinase inhibitors target a specific protein found on certain cancer cells. By blocking this protein, cancer cell growth may be slowed or stopped.

What are the possible side effects of acalabrutinib (Calquence)?

The most common side effects of taking this drug include:

Things to know about acalabrutinib (Calquence)

Acalabrutinib (Calquence) should not be given to people with severe liver disease. People taking this drug should be watched for signs of serious infections, heavy bleeding, cancers, and heart flutter (atrial fibrillation).2

Acalabrutinib should not be taken with CYP3 inhibitors, CYP3A inducers, or gastric acid drugs such as proton pump inhibitors and antacids.2

Dosing information

Take 100 mg of acalabrutinib (Calquence) by mouth every 12 hours. The capsules should be swallowed whole with water, not broken or chewed. It may be taken with or without food.2

Learn more about acalabrutinib (Calquence) by reading the prescribing information. The company AstraZeneca makes this drug.

This article represents the opinions, thoughts, and experiences of the author; none of this content has been paid for by any advertiser. The team does not recommend or endorse any products or treatments discussed herein. Learn more about how we maintain editorial integrity here.

  1. U.S. Food & Drug Administration. Project Orbis: FDA approves acalabrutinib for CLL and SLL. Available at: Accessed 11/21/19.
  2. Prescribing information. Available at: Accessed 11/21/19.


  • Ann Harper moderator
    2 months ago

    More good information. It’s just too bad that these drugs come with so many side effects. Thanks for sharing.

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