The Food and Drug Administration ( FDA ) has expanded the approved use of Imbruvica ( Ibrutinib ) for chronic lymphocytic leukemia ( CLL ) patients who have received at least one previous therapy.
Chronic lymphocytic leukemia is a rare blood and bone marrow disease that usually gets worse slowly over time, causing a gradual increase in white blood cells called B lymphocytes, or B cells.
The National Cancer Institute ( NCI ) estimates that 15,680 Americans were diagnosed and 4,580 died from the disease in 2013.
Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide. In November 2013, the FDA granted Imbruvica accelerated approval to treat patients with mantle cell lymphoma, a rare and aggressive type of blood cancer, if those patients received at least one prior therapy.
Imbruvica for chronic lymphocytic leukemia also received priority review and orphan-product designation because the drug demonstrated the potential to be a significant improvement in safety or effectiveness in the treatment of a serious condition and is intended to treat a rare disease, respectively.
The FDA’s accelerated approval of Imbruvica for chronic lymphocytic leukemia 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 mg orally administered dose of Imbruvica until the treatment reached unacceptable toxicity or the disease progressed.
Results showed nearly 58% 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.
The most common side effects observed in the clinical study include: thrombocytopenia, diarrhea, bruising, neutropenia, anemia, upper respiratory tract infection, fatigue, musculoskeletal pain, rash, fever ( pyrexia ), constipation, peripheral edema, arthralgia, nausea, stomatitis, sinusitis and dizziness. ( Xagena )
Fonte: FDA, 2014