|Brand name(s), other common name(s)||ImbruvicaTM|
|Drug type||BTK inhibitor|
|How the drug is given||By mouth|
Ibrutinib has been FDA-approved to treat patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. Ibrutinib has also been FDA-approved for chronic lymphocytic leukemia (CLL) patients who have received at least one previous therapy.
The FDA's accelerated approval of Imbruvica for CLL is based on a clinical study of 48 previously treated participants. On average, participants were diagnosed with CLL 6.7 years prior to the study and had received four previous therapies. All study participants received a 420 milligram orally administered dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed. Results showed nearly 58 percent of participants had their cancer shrink after treatment (overall response rate). At the time of the study, the duration of response ranged from 5.6 to 24.2 months. An improvement in survival or disease-related symptoms has not been established.
Side effects needing medical attention:Low blood platelet count; diarrhea; low white blood cell count; low red blood cell count; fatigue; muscle and bone pain; swelling of legs and feet; upper respiratory tract infection; nausea; bruising; shortness of breath; constipation; rash; stomach (abdomen) pain; vomiting; decreased appetite; fever; joint pain; mouth sores; sinus infection; and dizziness.
Serious side effects: Bleeding problems; infections; decrease in blood cell counts; kidney problems; second primary cancers.