Newly Diagnosed MCL? Discover a New Treatment Combination with Acalabrutinib

People with mantle cell lymphoma (MCL) now have access to a newly approved first treatment option that includes the BTK inhibitor acalabrutinib. In this article, you’ll learn how this combination compares to a previous standard treatment for newly diagnosed MCL.  

FDA approval brings a new option for untreated MCL

In January 2025, the U.S. Food and Drug Administration (FDA) approved a treatment combination for adults with MCL who are not eligible for an autologous stem cell transplant. The combination includes acalabrutinib (Calquence, AstraZeneca), bendamustine (Bendeka, Teva), and rituximab (Rituxan, Genentech).

This regimen builds on one of the recommended first-line MCL treatments of bendamustine and rituximab by adding acalabrutinib, a targeted therapy that helps disrupt cancer cells.

The approval also shifts acalabrutinib from its typical use in second-line MCL treatment to the first-line setting. This gives patients earlier access to a targeted therapy combination that may improve treatment outcomes. 

How the treatment was studied in a clinical trial 

The FDA approval was based on results from the ECHO study, a clinical trial that included 598 adults with untreated MCL who were 65 or older and not eligible for a stem cell transplant.

Participants were split into two groups:

• One group received acalabrutinib with bendamustine and rituximab
• The other group received a placebo with bendamustine and rituximab

Researchers measured progression-free survival, or how long individuals lived without cancer worsening. 

With nearly 4 years of follow-up:

• People taking acalabrutinib had an average of 66.4 months of progression-free survival
• Those in the placebo group had an average of 49.6 months of progression-free survival
• The acalabrutinib group had a 27% lower risk of cancer progression or death compared to the placebo group

These findings are important because they show that adding acalabrutinib to the standard treatment may help control MCL for a longer period of time.

Side effects that may occur with this treatment combination

As with most cancer treatments, there were side effects reported. In the ECHO trial, 69% of people who took acalabrutinib with bendamustine and rituximab experienced side effects that required hospital supportive management. 

These included pneumonia, COVID-19, fever, secondary cancers, rash, low white blood cell count with fever (febrile neutropenia), irregular heartbeat (atrial fibrillation), blood infections (sepsis), and anemia. 

It’s important to be aware of possible risks so you and your healthcare team can discuss them when considering treatment options. Understanding the potential side effects also helps patients plan ahead and work with their care team to manage them. 

Key takeaways for newly diagnosed MCL patients

The approval of acalabrutinib with bendamustine and rituximab provides an improved treatment option to newly diagnosed adults with mantle cell lymphoma who aren’t eligible for a stem cell transplant. The combination has been shown to help limit MCL progression longer than bendamustine and rituximab alone. 

If you are considering this treatment, talk with your MCL specialist about whether it is right for you. 

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Source: 

• FDA approves acalabrutinib with bendamustine and rituximab for previously untreated mantle cell lymphoma