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 is not distributed through mainland China's retail pharmacy network. Uwell Cloud can help arrange a purchase channel for this medicine, sourced and dispatched from Hong Kong; clinical administration support in China can be coordinated on request. Availability and eligibility for any specific patient are determined by clinical review.

Regulatory Approvals

• FDA — Approved (2017) — Sources
• EMA — Approved (2020) — Sources
• NMPA — Approved (2023) — Sources

Pivotal Clinical Evidence

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

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/