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FDA Grants Approval of Calquence for the Treatment of Mantle Cell Lymphoma

The US Food and Drug Administration (FDA) has granted approval to Calquence (acalabrutinib) for the treatment of patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Calquence is a highly-selective, potent Bruton tyrosine kinase (BTK) inhibitor being evaluated for the treatment of multiple B-cell cancers.

About mantle cell lymphoma

Mantle cell lymphoma (MCL) is an aggressive B-cell non-Hodgkin lymphoma (NHL) with poor prognosis.  MCL accounts for approximately 3% to 6% of new NHL cases in Western countries each year.  The median age at diagnosis is 68 years, with a 3:1 male predominance.1,2,3

About Calquence (acalabrutinib)

Calquence is an inhibitor of Bruton tyrosine kinase. Calquence was granted Orphan Drug Designation by the FDA for the treatment of patients with MCL. The drug works by permanently binding BTK, which is part of a chain of proteins that relays growth signals from the surface of B cells to genes in the cell nucleus enabling cancer cells to survive and grow. Drugs that block BTK stop the flow of these growth signals and the B cells die. Unlike Imbruvica™ (ibrutinib), the first BTK approved data reported from a clinical study suggests that Calquence may more selectively block the BTK pathway and avoid some known side effects.4


  1. Leukemia & Lymphoma Society. Mantle Cell Lymphoma Facts. Accessed June 2017
  2. Cheah CY, Seymour JF, Wang M. Mantle Cell Lymphoma. Journal of Clinical Oncology 34, no. 11 (April 2016) 1256-1269.
  3. Hoster E, Klapper W et al. Confirmation of the Mantle-Cell Lymphoma International Prognostic Index in Randomized Trials of the European Mantle-Cell Lymphoma Network. Journal of Clinical Oncology 2014;32:1338-1346.

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