FDA Approves Mantle Cell Lymphoma Treatment

Good news for mantle cell lymphoma patients! A new treatment called Calquence has just received approval from the U.S. Food and Drug Administration (FDA) for adults who suffer from this rare disease.

If you’re not familiar with mantle cell lymphoma (MCL), it’s one of the non-Hodgkin’s lymphomas. Non-Hodgkin’s lymphomas are cancers affecting the lymphatic system. MCL only accounts for 3-10% of them, but it’s a notably aggressive type.

MCL is characterized as a B-cell lymphoma that rises out of cancerous white blood cells in a specific area in the lymph nodes called the mantle zone. It usually results from a mistake in the creation of white blood cella. This makes the white blood cell reproduce uncontrollably. The lymph region grows, and the cells spill out to other body parts. By the time the disease is caught, it often has already reached other regions of the body, which makes recovery far less likely.
While the exact cause is unknown, it seems that there are genetic factors at play. The symptoms include stomach issues, a lack of appetite, mysterious weight loss, persistent fever, swollen glands, bowel problems, and lower back pain. To learn more about this rare cancer, click here.

Calquence essentially blocks an enzyme that the cancer needs to replicate. Overall, 81% of trial patients with MCL who received the new treatment had some form of response. 40% showed a full response, and 41% showed a partial one. Response time took about 2 months. Since it’s always unclear which treatments will work for which patients, it’s exciting to have a new choice to pursue.

Unfortunately, there are some unpleasant side effects that come along with the new drug. It can cause headaches, fatigue, bruising, diarrhea, neutropenia, myalgia, thrombocytopenia, and anemia. There are also some more severe side effects, such as internal bleeding, irregular heartbeat, and infections. It may even put patients at risk for secondary cancers. Women breastfeeding babies are especially discouraged from taking the medicine, as it may hurt their child.

Calquence was on the fast-track to approval. It had received Breakthrough Therapy, as well as Priority Review designations, since it offered a major improvement over the available therapies. It also qualified for Orphan Drug designation, since it treats a rare disease. This helps financially support the production of treatments that might not otherwise be feasible to develop.

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