The U.S. Food and Drug Administration (FDA) has granted approval for a new oral treatment targeting mantle cell lymphoma (MCL), a rare and aggressive form of blood cancer. The drug, known as Calquence, is produced by AstraZeneca and is designed to inhibit the enzyme Bruton’s tyrosine kinase (BTK), which is crucial for the growth and spread of cancerous B cells. This approval marks a significant advancement in cancer treatment, offering new hope to patients battling this challenging disease.
Recent clinical trials demonstrate that the combination therapy involving Calquence significantly reduces the risk of disease progression or death by 27%. Participants on the Calquence regimen lived an average of 66.4 months without their cancer worsening, a notable improvement compared to the 49.6 months observed in patients receiving standard treatment. The trial involved 598 individuals aged 65 or older who had not previously received treatment for MCL.
Calquence's journey began with a provisional approval in 2017, and the recent full endorsement by the FDA underscores its efficacy and safety profile. The safety outcomes in the latest trials align with previous findings, with no new safety concerns identified. Additionally, acalabrutinib, Calquence's active ingredient, received full approval for use in patients with previously treated MCL.
Mantle cell lymphoma, typically diagnosed in individuals in their 60s, presents significant challenges due to its aggressive nature and advanced stage at diagnosis. Annually, approximately 4,000 new cases are reported in the United States. The introduction of Calquence offers a pivotal option for treatment, combining oral convenience with proven effectiveness.
Despite this promising development, patients must remain aware of potential side effects. Serious adverse reactions such as 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 trial participants.
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