FDA Approves Treatment for Mantle Cell Lymphoma in Adults

On October 31st of this year, the FDA issued a press release letting the public know of a newly authorized treatment option for adults with mantle cell lymphoma. The medicine is called Calquence, and its scientific name is acalabrutinib. The drug acts as an inhibitor against enxymes that promote the growth of cancerous cells. It is available to individuals who have had at least one prior therapy for the treatment of mantle cell lymphoma, a rare and particularly aggressive blood cancer that most commonly affects older adults.

Richard Pazdur, MD, who serves as the director of the FDA’s Oncology Center of Excellence, stated in the release that “mantle cell lymphoma is a particularly aggressive cancer.” Alternative treatment options have gone largely under-researched since it is found in only a small percentage of lymphoma cancer cases. Pazdur claims that “for patients who have not responded to treatment or have relapsed, Calquence provides a new treatment option that has shown high rates of response for some patients in initial studies.”

Since Calquence meets a need in the medical industry that has gone largely unmet, it has approved quickly under an accelerated approval program. A single-arm trial conducted on 124 patients found the drug to be effective in 81% of the patients, which minimal side effects or side effects common in all cancer treatment medications. This new breakthrough in medication may improve the survival rates of those with the rare form of lymphoma, and may lead to future breakthrough studies in the treatment and prevention of cancer.

Mantle cell lymphoma

Although lymphoma is the most common blood cancer, mantle cell lymphoma is one of the rarest forms of lymphoma that a person can be diagnosed with. It is a type of non-Hodgkin lymphoma which starts in the B-cells, and originates in the “mantle zone” of the lymph node, giving the cancer its name. It is most common in men who are 60-years-old or older, and is usually very aggressive.

It can be hard to diagnose mantle cell lymphoma, and as a result, it is usually not found and diagnosed until after the cancer has spread, most commonly to the gastrointestinal tract and to the bone marrow. Cancer can only be officially diagnosed after a tissue sample of a tumor is found to be cancerous, but mantle cell lymphoma patients typically have to go through additional tests of their blood and bone marrow before the diagnosis can be confirmed. There are several proteins that can be examined to help with the diagnosis, but as with all testing, the results can take time to process and be acted upon.

Traditionally, mantle cell lymphoma is treated with a combination of chemotherapy and stem cell therapy. Due to the often-aggressive nature of the cancer, chemotherapy is prescribed as rigorously as a person’s health allows them to be treated. In some cases, mantle cell lymphoma can be detected early, and can move slowly, in which case doctors can choose to monitor the disease through “active surveillance” or “watchful waiting” until something concrete happens.

Several different medicines have been developed to treat individuals with mantle cell lymphoma, but they have been met with varying success. There has not yet been one prescription alone that has had a strong enough impact on the disease to enter mainstream treatment options. Part of the issue is that the disease is too rare for a large number of clinical trials to take place. Existing treatments are always liable to be replaced by more current, more effective treatment options.