CALQUENCE acalabrutinib

Drug Class

Bruton's tyrosine kinase inhibitor

Mechanism

Selectively and covalently inhibits Bruton's tyrosine kinase (BTK), blocking BCR-mediated activation of B-cells.

Approved Indication

Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy, or chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

What This Means For Patients

Calquence (acalabrutinib) is a targeted therapy that shuts down BTK kinase signals to inhibit B-cell survival in leukemia and mantle cell lymphoma. It is accessible to eligible patients in the Hainan Boao Lecheng pilot zone under the special-import regulatory policy.

Regulatory Approvals

• FDA — approved (2017) — label
• EMA — approved (2020) — source
• NMPA — approved (2023) — source

Pivotal Clinical Evidence

• ELEVATE-TN — Sharman et al., Lancet 2020 (NCT02475681) — DOI

Sources

• https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/210259s007s008lbl.pdf
• https://www.ema.europa.eu/en/medicines/human/EPAR/calquence
• https://www.nmpa.gov.cn/