Key Advantages of the New Tablet Formulation
- New formulation can be co-administered with gastric acid-reducing agents
- Tablet offers equivalent efficacy, safety and consistent dosing compared to current capsule
5 August 2022 -- AstraZeneca’s new tablet formulation of Calquence (acalabrutinib) has been approved in the US for all current indications, including adult patients with chronic lymphocytic leukaemia (CLL), small lymphocytic lymphoma (SLL) and for patients with relapsed or refractory mantle cell lymphoma (MCL), which is approved under accelerated approval based on overall response rate.
Basis for FDA Approval
The approval by the US Food and Drug Administration (FDA) was based on results from the ELEVATE-PLUS trials presented during the 63rd American Society of Hematology (ASH) Annual Meeting & Exposition in December 2021.
Efficacy, Safety and Administration of the Tablet Formulation
In the trials, results showed the Calquence capsule and tablet formulations are bioequivalent, indicating the same efficacy and safety profile can be expected with the same dosing strength and schedule. The tablet can be taken with gastric acid-reducing agents, including proton pump inhibitors (PPIs), antacids and H2-receptor antagonists (H2RAs). The majority of observed adverse events (AEs) in these studies were mild with no new safety concerns identified.
Expert Commentary
John C. Byrd, MD, Chair of the Department of Internal Medicine at the University of Cincinnati, said: “Patients with blood cancers like chronic lymphocytic leukaemia and mantle cell lymphoma are often older and may face multiple medical conditions that may need intervention, including acid reflux or peptic ulcer disease. The US approval of acalabrutinib in a tablet form enables co-administration of the acalabrutinib tablet alongside a proton pump inhibitor. This provides another option for some patients with chronic lymphocytic leukaemia and relapsed or refractory mantle cell lymphoma, enabling more patients to potentially benefit from this treatment.”
AstraZeneca Official Commentary
Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “Today’s approval of the new Calquence tablet formulation will offer physicians and patients increased flexibility when devising treatment plans for chronic lymphocytic leukaemia and mantle cell lymphoma. This new option is a result of our focus on understanding the wants and needs of this community and providing patient-focused solutions for their treatment.”
Global Approval Status of Calquence Formulations
Calquence is also approved as a capsule formulation for the same indications as the tablet in the US and in many other countries worldwide. Indications may vary by market.
Overview of Chronic Lymphocytic Leukaemia (CLL)
CLL is the most prevalent type of leukaemia in adults, with over 100,000 new cases globally in 2019 and an estimated 20,160 new cases in the US in 2022. Although some people with CLL may not experience any symptoms at diagnosis, others may experience symptoms, such as weakness, fatigue, weight loss, chills, fever, night sweats, swollen lymph nodes and abdominal pain.
In CLL, there is an accumulation of abnormal lymphocytes within the bone marrow. As the number of abnormal cells increases, there is less room within the marrow for the production of normal white blood cells, red blood cells and platelets. This could result in anaemia, infection and bleeding. B-cell receptor signalling through BTK is one of the essential growth pathways for CLL.
Overview of Mantle Cell Lymphoma (MCL)
MCL is an uncommon subtype of B-cell non-Hodgkin lymphoma. MCL comprises about 3-6% of non-Hodgkin lymphomas, with an annual incidence of 0.5 per 100,000 population in Western countries; in the US, it is estimated that approximately 4,000 new cases of MCL are diagnosed each year. While MCL patients initially respond to treatment, patients do tend to relapse.
