The U.S. Food and Drug Administration (FDA) has approved Imbruvica™ (ibrutinib) for the treatment of patients with mantle cell lymphoma, a rare and aggressive type of blood cancer.
Non-Hodgkin’s lymphoma (NHL) is a form of cancer that begins in the cells of the lymph system. It is characterized by the excessive accumulation of atypical (cancerous) lymphocytes. These lymphocytes can crowd the lymph system and suppress the formation and function of other immune and blood cells. Mantle cell lymphoma (MCL) is a subset of NHL that accounts for approximately 5%–10% of all lymphomas. By the time MCL is diagnosed, it usually has already spread to the lymph nodes, bone marrow and other organs.
Imbruvica is a targeted agent that works by inhibiting the enzyme needed by the cancer to multiply and spread. The drug’s approval was based on the results of a study that included 111 patients with MCL who were given Imbruvica daily until their disease progressed or side effects became intolerable. Results of the study indicated that nearly 66 percent of patients experienced an objective response—meaning their cancer shrank or disappeared after treatment.
The most common side effects reported in participants receiving Imbruvica are low levels of platelets in the blood (thrombocytopenia), diarrhea, a decrease in infection-fighting white blood cells (neutropenia), anemia, fatigue, musculoskeletal pain, swelling (edema), upper respiratory infection, nausea, bruising, shortness of breath (dyspnea), constipation, rash, abdominal pain, vomiting, and decreased appetite. Other clinically significant side effects include bleeding, infections, kidney problems and the development of other types of cancers.
Imbruvica has received the FDA’s new breakthrough therapy designation given to experimental drugs deemed to be potentially important advances in treating serious diseases. The drug was approved as part of the FDA’s accelerated approval program, which provides earlier access to promising new drugs while the company conducts confirmatory clinical trials. What’s more, Imbruvica was approved as part of the FDA’s priority review program, which allows an expedited six-month review of drugs that may offer major advances in treatment—and the drug also received orphan-product designation because it is intended to treat a rare disease.
FDA approves Imbruvica for rare blood cancer. [FDA News Release]. U.S. Food and Drug Administration website. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm374761.htm
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