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

Mary L Windle, PharmD

Disclosures

January 11, 2018

In This Article

Calquence (acalabrutinib)

Indication:

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

Mechanism:

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.

Dosage:

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

Approval:

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%.

Reference:

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.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....