FDA Approves Imbruvica Drug for Rare Blood Cancer

The U.S. Food and Drug Administration has recently approved a medication that will treat a rare and aggressive type of blood cancer for patients with mantle cell lymphoma (MCL).

This rare form of non-Hodgkin lymphoma is present in approximately 6 percent of all non-Hodgkin lymphoma cases, according to the FDA. However, by the time it is diagnosed, it has usually spread to other organs throughout the lymph nodes, bone marrow and surrounding tissues.

The agency noted that the drug was granted an accelerated approval in August, giving it the second breakthrough therapy status to receive FDA clearance

"Imbruvica's approval demonstrates the FDA's commitment to making treatments available to patients with rare diseases," Richard Pazdur said, the director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.

The approval rating was based on a clinical trial from 111 patients that had previously been treated for MCL who received Imbruvica for disease progression or its development of intolerable side effects.

Findings showed that 65.8 percent of patients experienced tumor shrinkage or disappearance after treatment with the drug during a median duration of response for 17.5 months.

The drug's most common side effects have been reported by participants has low levels of platelets in the blood, diarrhea, a decrease in infection-fighting white blood cells, anemia, fatigue, musculoskeletal pain, swelling (edema), upper respiratory infection, nausea, bruising, shortness of breath, constipation, rash, abdominal pain, vomiting, and decreased appetite. Other problems also included bleeding, infections, kidney problems and possibly the development of rare cancers.