Feb. 5. 2025 – The FDA has approved a new pill to treat adults with a type of blood cancer called mantle cell lymphoma (MCL).
This treatment is for people who are newly diagnosed or haven't had treatment yet and aren’t able to get a stem cell transplant. It combines a medicine called acalabrutinib with standard chemotherapy and immune therapy. The FDA also fully approved acalabrutinib on its own for people with MCL who have already been treated before. It was first given a temporary approval in 2017.
MCL is a rare and aggressive cancer that affects B cells, a type of white blood cell. It can spread quickly to other parts of the body, like the bone marrow, liver, and digestive tract. Typically diagnosed in people in their 60s, MCL is often found at an advanced stage. About 4,000 new cases are diagnosed annually in the United States. While patients usually respond to early treatment, relapse is common, highlighting the need for more effective, well-tolerated options, especially for older patients.
Acalabrutinib, made by the drug company AstraZeneca and marketed under the brand name Calquence, works by blocking an enzyme called Bruton’s tyrosine kinase (BTK), which helps cancerous B cells grow and spread. It's combined with bendamustine, a chemotherapy drug that damages cancer cell DNA, and rituximab, an immunotherapy drug that targets and kills cancerous B cells. Both are given through an IV and were approved by the FDA in 2008 and 1997, respectively.
A clinical trial, involving 598 patients who were 65 or older and had untreated MCL, tested how well the treatment worked. The people in the study were randomly assigned to receive either Calquence plus chemoimmunotherapy (bendamustine and rituximab) or a placebo plus chemoimmunotherapy. The new drug combination reduced the risk of disease progression or death by 27%, with patients on the Calquence combination living an average of 66.4 months without their cancer getting worse, compared to 49.6 months on standard treatment.
Serious side effects – including pneumonia, COVID-19, fever, rash, irregular heartbeat, severe infection, low white blood cell count with fever, and anemia – were reported in more than 2% of patients. The safety of Calquence was consistent with that found in previous trials, with no new concerns identified, according to a news release by AstraZeneca.
