The U.S. Food and Drug Administration (FDA) has granted accelerated approval to a new targeted treatment called sonrotoclax (Beqalzi) for adults with mantle cell lymphoma (MCL) that has come back or stopped responding to treatment.
This approval is for people who have already received at least two prior therapies, including a type of drug known as a BTK inhibitor, which is commonly used to treat MCL.
In a clinical trial of 103 patients, just over half (52%) saw their cancer shrink or disappear after treatment with sonrotoclax. Many patients responded quickly, with results seen in less than two months on average. Among those who responded, the benefits lasted a median of about 16 months.
Sonrotoclax works by targeting a protein called BCL-2, which helps cancer cells survive. By blocking this protein, the drug can help trigger cancer cell death.
Because this is an accelerated approval, it is based on early evidence that the treatment is effective. Additional studies are ongoing to confirm its long-term benefits.
Like many cancer treatments, sonrotoclax can cause side effects. Serious risks include tumor lysis syndrome (a potentially dangerous reaction caused by rapid cancer cell breakdown), infections such as pneumonia, and low white blood cell counts, which can increase infection risk.
To help reduce the risk of tumor lysis syndrome, treatment begins with a gradual dose increase over four weeks, followed by a once-daily pill taken as long as the treatment is working and side effects are manageable.
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