Calquence (Acalabrutinib)

What it is and what it treats

Acalabrutinib, marketed as Calquence, is a second-generation, highly selective inhibitor of Bruton's tyrosine kinase (BTK), developed originally by Acerta Pharma and now part of AstraZeneca's oncology portfolio. It is authorised for adults with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL), both as first-line therapy and in the relapsed or refractory setting, and in some markets for adults with mantle cell lymphoma (MCL) who have received at least one prior therapy.

BTK is a signalling enzyme central to the B-cell receptor pathway that drives proliferation, adhesion and survival of malignant B-cells in CLL, SLL and MCL. Acalabrutinib binds BTK covalently and irreversibly but was specifically designed for greater target selectivity than first-generation BTK inhibitors, with the aim of reducing inhibition of off-target kinases implicated in cardiovascular adverse effects.

In a randomised head-to-head trial in previously treated CLL, acalabrutinib demonstrated progression-free survival comparable to ibrutinib, with a significantly lower incidence of atrial fibrillation or flutter. In treatment-naïve CLL trials, acalabrutinib-based regimens have shown substantial improvements in progression-free survival compared with chemoimmunotherapy, including in patients with high-risk cytogenetic features such as del(17p) or TP53 mutation.

Presentations and dosage forms

• 100 mg film-coated tablets
• Supplied in blister packaging for oral administration
• Earlier capsule presentations have been superseded in most markets by the film-coated tablet

How it is administered

The approved label describes a dose of 100 mg taken orally approximately every 12 hours (twice daily), continued until disease progression or unacceptable toxicity, as determined by the treating haematologist or oncologist. Tablets are swallowed whole with water and may be taken with or without food.

The film-coated tablet formulation was developed to remove the gastric-acid interaction associated with the original capsule presentation. The capsule required an acidic gastric environment for adequate absorption, meaning acid-reducing medicines such as proton-pump inhibitors could substantially lower drug exposure if co-administered without careful spacing. The tablet formulation is designed to be less dependent on gastric pH, simplifying co-administration with acid-suppressing therapies that are common in this patient population.

The label describes no dose adjustment for mild-to-moderate renal or hepatic impairment. Dose interruptions or reductions are described for specific adverse reactions, including bleeding, infection or cytopenias, and are managed by the treating clinical team. Co-administration with strong CYP3A inhibitors or inducers is addressed in the prescribing information because of altered acalabrutinib exposure.

Storage and handling

• Store below 30 °C in the original packaging
• Keep blister strips in the outer carton to protect from moisture
• Keep out of the reach of children
• Do not use beyond the expiry date printed on the pack

Side effects

The prescribing information for Calquence, based on trials across CLL, SLL and MCL, describes a range of common reactions alongside labelled serious risks that require monitoring throughout treatment.

Commonly reported

Serious effects requiring medical attention

Patients should seek prompt medical attention for unusual bleeding or bruising, palpitations, or signs of infection such as fever, and should report suspected adverse reactions through their national pharmacovigilance scheme, such as the MHRA Yellow Card Scheme or FDA MedWatch.

Calquence compared with ibrutinib

Ibrutinib (Imbruvica) was the first BTK inhibitor authorised for CLL and remains widely used. It inhibits BTK along with several other kinases, a broader profile that has been associated in trials with higher rates of atrial fibrillation, hypertension and bleeding compared with the more selective acalabrutinib. In a randomised head-to-head trial in previously treated CLL, acalabrutinib showed non-inferior progression-free survival to ibrutinib with a significantly lower rate of atrial fibrillation or flutter.

Ibrutinib is dosed once daily, whereas acalabrutinib requires twice-daily dosing, a practical difference that can affect adherence preferences. Ibrutinib also holds authorisation in some additional indications, such as Waldenström's macroglobulinaemia and chronic graft-versus-host disease, where acalabrutinib is not approved. The choice between the two agents in a given patient is made by the treating haematologist, taking into account cardiovascular history, bleeding risk, concomitant medicines and dosing preference.

Availability and supply route

Calquence is registered in numerous countries, but authorised strengths, pack presentations and continuous commercial supply vary by market, and the transition from the earlier capsule to the current film-coated tablet has not occurred uniformly everywhere. Haematology and oncology units sometimes need to source specific presentations through channels beyond their immediate domestic supply chain.

Where local registration or supply is temporarily unavailable, hospitals and specialist pharmacies may use named-patient import routes, permitted under most national regulatory frameworks, to obtain an internationally authorised medicine for a specific, identified patient under direct physician responsibility. This requires a valid prescription and appropriate import documentation and is distinct from general retail sale.

Pharmacy Remedy is a licensed pharmaceutical wholesaler based in Turkey that supplies hospitals, haematology and oncology clinics, and licensed pharmacies against valid prescriptions and institutional documentation. It operates within licensed business-to-business pharmaceutical supply chains and does not sell Calquence, or any prescription oncology medicine, directly to members of the public.

Frequently asked questions

Primary sources

• FDA — Calquence prescribing information
• EMA — Calquence EPAR

Further reading and regulatory routes

• Which country Calquence is sourced from, and why prices differ
• How to verify a medicine is genuine
• Why medicines cost less in Türkiye
• WHO falsified medicine alerts
• Named patient supply
• UAE import guide
• For healthcare professionals
• All medicine monographs

Related medicines

• Tasigna (nilotinib)
• Xospata (gilteritinib)
• Erivedge (vismodegib)