The U.S. Food and Drug Administration today expanded the approved use of Imbruvica (ibrutinib) for chronic lymphocytic leukemia (CLL), a rare blood and bone marrow disease that gradually increases white blood cells called B cells (B lymphocytes). According to the agency, Imbruvica works by blocking the cancer cells’ ability to grow and divide.
“This approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy,” stated Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research
The FDA granted accelerated approval of the drug based on a clinical trialstudy of 48 patients who had been diagnosed with CLL approximately 7 years prior to the study, and had undergone four previous therapies. Each of them were given a 420 milligram orally administered dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed (generally 5.6-24.2 months). According to the researchers, results showed “nearly 58% of participants had their cancer shrink after treatment.”
It is important to note, however, an improvement in survival or disease-related symptoms has not been established.
The most common side effects experienced by participants included dizziness, low levels of platelets in the blood, diarrhea, constipation, fever, upper respiratory tract infection, sinus infection, bruising, a decrease in infection-fighting white blood cells, anemia, fatigue, joint pain, pain in the muscles and bones, rash, peripheral edema, nausea, and mouth sores,
For more information about chronic lymphocytic leukemia, readers can contact the Leukemia & Lymphoma Society, 1311 Mamaroneck Ave., White Plains, NY 10605 914 949-5213.