The U.S. Food and Drug Administration approved Wednesday the use of Imbruvica (ibrutinib) as treatment for patients with a rage, aggressive type of blood cancer called “mantle cell lymphoma (MCL).”
Imbruvica inhibits the enzyme required for the multiplication and spread of the cancer cells. It is the third approved medicine for the treatment of MCL. Velcade and Revlimid are the first two. Furthermore, it is the second drug with breakthrough therapy designation to obtain federal agency approval.
Imbruvica is intended for MCL patients who have received no less than one prior therapy.
MCL is a rare and aggressive type of blood cancer which accounts for about six percent of all non-Hodgkin lymphoma cases. As soon as MCL is detected it has most probably spread to the bone marrow, lymph nodes, and other body organs.
Dr. Richard Pazdur, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a news release, “Imbruvica’s approval demonstrates the FDA’s commitment to making treatments available to patients with rare diseases.”
Pazdur added, “The agency worked cooperatively with the companies to expedite the drug’s development, review and approval, reflecting the promise of the Breakthrough Therapy Designation program.”
The researchers recruited 111 participants to take Imbruvica on a daily basis until their disease progressed or the side effects became unbearable.
The results of the study showed that after the treatment, 66 percent of the participants showed improvement on their conditions. Their cancer either shrunk or disappeared. However, disease-related symptoms and the progress in survival or has not been established.
Low platelet counts (thrombocytopenia), decreased count of infection-fighting white blood cells (neutropenia), anemia, bruising, nausea, vomiting, diarrhea, constipation, fatigue, abdominal pain, musculoskeletal pain, respiratory infection, decreased appetite, swelling (edema), and shortness of breath (dyspnea) are the most common side effects of taking in Imbruvica.
Other clinically significant side effects include infections, bleeding, kidney problems and the progress of other types of cancers.
