Acalabrutinib (Calquence)

General information

Class/mechanism: Irreversible inhibitor of Bruton's tyrosine kinase (BTK), which is an enzyme that participates in the B-cell receptor (BCR) signal cascade and cytokine receptor pathways. BCR signaling is believed to promote cell proliferation, adhesion, and survival in B-cell malignancies. Inhibition of BTK interferes with the processes above, as well as B-cell chemotaxis and trafficking. More specific to BTK than the first-generation drug ibrutinib.^[1]^[2]^[3]
Route: PO
Extravasation: n/a

For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is established

Patient drug information

History of changes in FDA indication

2017-10-31: Granted accelerated approval for treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. (Based on ACE-LY-004)
2019-11-21: Approved for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (Based on ELEVATE TN and ASCEND)

History of changes in EMA indication

2020-11-05: Initial authorization as Calquence as monotherapy or in combination with obinutuzumab is indicated for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL).
2020-11-05: Initial authorization as Calquence as monotherapy is indicated for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy.

History of changes in Health Canada indication

2019-08-23: Initial notice of compliance

History of changes in PMDA indication

2021-01-22: Newly indicated for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.

Also known as

Code name: ACP-196
Brand name: Calquence

References

[insert-1] 1.0 ^1.1 ^1.2 Acalabrutinib (Calquence) package insert

[2] Acalabrutinib (Calquence) package insert (locally hosted backup)

[3] Calquence manufacturer's website

[4] Acalabrutinib (Calquence) patient drug information (Chemocare)

[5] Acalabrutinib (Calquence) patient drug information (UpToDate)

[1]

[2]

[3]

[4]

[5]