CALQUENCE

What it is

CALQUENCE contains acalabrutinib maleate monohydrate equivalent to 100 mg of acalabrutinib, presented as orange film-coated tablets. Acalabrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK) that forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK enzymatic activity. BTK is a signalling molecule of the B-cell antigen receptor and cytokine receptor pathways; in B-cells, BTK signalling results in activation of pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion.

Approved indications

— Mantle cell lymphoma (MCL) as monotherapy in patients who have received at least one prior therapy. — Previously untreated mantle cell lymphoma (MCL) in combination with bendamustine and rituximab in adult patients not eligible for autologous haematopoietic stem cell transplantation. — Chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL).

Dosing overview

The recommended dose of CALQUENCE in monotherapy or in combination for mantle cell lymphoma is 100 mg twice daily. The recommended dose for the treatment of chronic lymphocytic leukaemia is 100 mg twice daily, either as monotherapy or in combination with obinutuzumab. Doses should be separated by approximately 12 hours. CALQUENCE should be swallowed whole with water at approximately the same time each day and can be taken with or without food.

Key safety warnings

**Haemorrhage.** Serious haemorrhagic events, including fatal events, have occurred in patients with haematological malignancies treated with CALQUENCE monotherapy, with major haemorrhage occurring in 5.5% of patients and fatalities in 0.1%. Use of antithrombotic agents concomitantly with CALQUENCE may increase the risk of haemorrhage; 3% of patients taking CALQUENCE without antithrombotic agents experienced major haemorrhage, compared with 4.3% when antithrombotic agents were added. **Infection.** Serious infections, including fatal events, have occurred in patients treated with CALQUENCE monotherapy, with Grade 3 or higher infections in 26.4%. Infections due to hepatitis B virus reactivation, aspergillosis, and progressive multifocal leukoencephalopathy have occurred. **Cytopenias.** Patients treated with CALQUENCE monotherapy commonly experienced Grade 3 or higher cytopenias, including neutropenia (17.5%), anaemia (9.5%) and thrombocytopenia (6.2%). **Second primary malignancies.** Second primary malignancies, including non-skin cancers, occurred in 17.6% of patients, with skin cancer being the most frequent at 9.9%. **Atrial fibrillation and flutter.** Atrial fibrillation and atrial flutter of any grade occurred in 7.4% of patients and Grade 3 or higher in 2.3%.

Contraindications

There are no contraindications to CALQUENCE.

PBS listing

CALQUENCE 100 mg tablets are listed on the PBS with 4 items, authority required restriction, and an ex-manufacturer price of A$6889.37.

Regulatory history

CALQUENCE acalabrutinib 100 mg was first registered on the ARTG as a capsule formulation on 21 November 2019, followed by registration of a film-coated tablet formulation on 13 October 2022. In March 2020, PBAC recommended CALQUENCE for listing on a cost-minimisation basis to ibrutinib for the treatment of patients with relapsed or refractory chronic lymphocytic leukaemia or small lymphocytic lymphoma considered unsuitable for treatment or retreatment with a purine analogue. In July 2021, PBAC recommended listing for relapsed and/or refractory mantle cell lymphoma. In July 2023, PBAC recommended CALQUENCE for chronic lymphocytic leukaemia or small lymphocytic lymphoma. In July 2025, PBAC recommended CALQUENCE for first-line treatment of Stage III or IV mantle cell lymphoma in combination with bendamustine and rituximab in patients ineligible for stem cell transplantation, noting it is more effective at preventing progression than bendamustine and rituximab alone but associated with increased risk of infections.