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.Acalabrutinib (Calquence) package insert Acalabrutinib (Calquence) package insert (locally hosted backup)Calquence manufacturer's website
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 or the prescribing information.
==Diseases for which it is established==
*Chronic lymphocytic leukemia
*Mantle cell lymphoma
==Patient drug information==
*Acalabrutinib (Calquence) package insert
*Acalabrutinib (Calquence) patient drug information (Chemocare)Acalabrutinib (Calquence) patient drug information (Chemocare)
*Acalabrutinib (Calquence) patient drug information (UpToDate)Acalabrutinib (Calquence) patient drug information (UpToDate)
==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)
**2025-01-16: Granted traditional approval as a single agent for adults with previously treated MCL.
*2019-11-21: Approved for adults with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (Based on ELEVATE TN and ASCEND)
*2025-01-16: Approved with bendamustine and rituximab for adults with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). (based on ECHO)
==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==
Category:Drugs
Category:Oral medications
Category:BTK inhibitors
Category:Chronic lymphocytic leukemia medications
Category:Mantle cell lymphoma medications
Category:FDA approved in 2017
Category:EMA approved in 2020
Category:Health Canada approved in 2019
Category:PMDA approved in 2021