On January 16, 2025, the drug Calquence (acalabrutinib) received expanded FDA approval for newly diagnosed MCL patients. Acalabrutinib can now be used in combination with two other drugs (bendamustine and rituximab) for adults with mantle cell lymphoma who have not been treated before and are not eligible for stem cell transplantation. This approval additionally converts acalubrtinib’s accelerated approval from 2017 to a full approval for adult patients with MCL treated with at least one prior therapy.
Benefits of the New Treatment
A large phase 3, randomized, double-blind, placebo-controlled clinical trial called ECHO showed significant improvements for patients:
- Patients receiving acalabrutinib with bendamustine and rituximab lived longer without their cancer worsening (66.4 months) compared to those receiving only bendamustine and rituximab (49.6 months).
- This means the new combination added about 17 months of time before the cancer progressed.
Side Effects
While the new treatment showed benefits, it’s important to be aware of potential side effects:
- Serious side effects occurred in 69% of patients.
- The most common serious side effects included pneumonia, COVID-19, fever, secondary cancers, rash, and blood-related issues.
Patients should discuss the potential risks and benefits with their healthcare team to determine if this new treatment option is right for them. This approval offers new hope for MCL patients, particularly those newly diagnosed who are not candidates for stem cell transplantation. If you or a loved one has MCL, consider discussing this new treatment option with your oncologist.
About Calquence
Calquence is a second-generation selective Bruton’s tyrosine kinase (BTK) inhibitor. BTK is a protein/carbohydrate complex that is involved in maintaining cellular survival and replication in some cancer cells. By inhibiting the activity of BTK, a BTK inhibitor reduces the growth of leukemia or lymphoma cells and causes cellular death. Drugs that block BTK stop the flow of these growth signals and the CLL cells die. Calquence may more selectively block the BTK pathway and avoid some known side effects of other BTK inhibitors. Calquence is also approved for the treatment of chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL).
More Reading
High dose Therapy and Stem Cell Transplant for Treatment of Mantle Cell Lymphoma
Mantle Cell Lymphoma: Treatment Overview
Brukinsa BTK Inhibitor Treatment for Lymphoma
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References
Wang M, Mayer J, Belada D, et al. ACALABRUTINIB PLUS BENDAMUSTINE AND RITUXIMAB IN UNTREATED MANTLE CELL LYMPHOMA: RESULTS FROM THE PHASE 3, DOUBLE-BLIND, PLACEBO-CONTROLLED ECHO TRIAL. Presented at the European Hematology Association 2024 Hybrid Congress in Madrid, Spain. LBA3439.
