Venetoclax with the BTK inhibitor acalabrutinib was FDA-approved as a first treatment for people with CLL on February 20, 2026. This is the first all-oral, fixed-duration regimen that is approved for CLL. This means that it is given as a pill for a set period of 14 months. 

Results from the phase 3 AMPLIFY trial showed that of patients treated with acalabrutinib and venetoclax, 77% were alive without cancer progression at three years. Those patients had a 35% lower risk of disease progression or death compared to those treated with chemoimmunotherapy. 

Side effect profile of venetoclax with acalabrutinib

The lists below show the percentage of people with CLL who experienced the 5 most common and severe side effects from venetoclax with acalabrutinib in the AMPLIFY trial. This information can help you understand what to expect and prepare for, and guide conversations with your care team about managing potential side effects.  

The 5 most common side effects (any grade) that CLL patients experienced after receiving venetoclax with acalabrutinib, apart from low blood counts, were: 

• Headache: 35%
• Diarrhea: 33%
• Muscle/bone pain: 25%
• COVID-19 infection: 21%
• Fatigue: 18% 

The 5 most severe side effects in which patients required supportive hospital care (grades 3 and higher), apart from low blood counts, included: 

• COVID-19 infection: 6%
• Diarrhea: 1.7%
• Headache: 1.4%
• Rash: 1%
• Muscle/bone pain: 0.7% 

During the clinical trial, around 8% of patients stopped treatment due to side effects. 

For more information on venetoclax with acalabrutinib for CLL, check out the source below.

• Calquence Prescribing Information 

For information on how to manage side effects, visit: Side Effect Management of CLL Therapies.

Financial resources for venetoclax and acalabrutinib

Click here to locate financial resources for venetoclax. For additional resources, click here to visit the financial support section of the guide.