FDA New Drug and Biologic Approvals -- 2017 Year-in-Review

Mary L Windle, PharmD


January 11, 2018

In This Article

Calquence (acalabrutinib)


Mantle cell lymphoma (MCL) in adults who have received at least 1 prior therapy.


Bruton tyrosine kinase (BTK) inhibitor. Acalabrutinib and its active metabolite, ACP-5862, form a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signaling molecule of the B-cell antigen receptor (BCR) and cytokine receptor pathways. In B cells, BTK signaling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.


100 mg PO every 12 hours. Continue until disease progression or unacceptable toxicity.


Approval was based on findings from the ACE-LY-004 phase 2, open-label trial (n=124), in which all patients received treatment with acalabrutinib. Investigator-assessed objective response rate (ORR) at a median follow-up of 15.2 months was 81% (95% confidence index [CI], 73%-87%). Complete response rate was 40% and partial response rate was 41%.


Wang M, et al. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial. Lancet. 2017 Dec 11.


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