FDA Approves J& J, Pharmacyclics Leukemia Drug
The United States Food and Drug Administration (FDA) has approved a drug for treating chronic lymphocytic leukemia (CLL), which is the slow progressing version of the cancer. Johnson & Johnson, Pharmacyclics' leukemia drug, Imbruvica, is to be used as a second line treatment.
"Today's approval provides an important new treatment option for CLL patients whose cancer has progressed despite having undergone previous therapy," Richard Pazdur, head of the FDA's Office of Hematology and Oncology Products, said reported by Reuters Health.
"The FDA completed its review of Imbruvica's new indication under the agency's accelerated approval process, which played a vital role in rapidly making this new therapy available to those who need it most."
Imbruvica, chemically known as ibrutinib, was originally approved by the agency in November for patients with mantle cell lymphoma who had tried at least one other kind of therapy. Mantle cell lymphoma is a rare and more aggressive form of non-Hodgkin lymphoma. The FDA's approval of this drug for CLL patients is also for second line therapy, which means that CLL patients must have tried at least one other form of therapy before trying Imbruvica.
The drug was approved after the FDA analyzed the clinical trials that involved 48 patients. The patients were diagnosed with CLL roughly an average of 6.7 years prior to the start of the study. They received an average of four treatments before qualifying for Imbruvica. The patients were given 420 milligrams of the drug per dose orally until the treatment would reach "unacceptable toxicity," according to the FDA's news release. Administration of the drug was also stopped if the disease continued to progress. The agency reported that for around 58 percent of the patients, the drug was effective in shrinking their cancers. The drug works by blocking the enzyme that encourages the cancer cells to grow and divide.
The trials concluded that the most common side effects were thrombocytopenia, peripheral edema, neutropenia, anemia, sinusitis, diarrhea, constipation, bruising, joint pain, musculoskeletal pain, fever, rash, nausea, dizziness and fatigue.
According to the National Cancer Institute, in 2013, CLL affected 15,850 Americans and killed 4,580. CCL is a rare blood and bone marrow disease that steadily increases the number of white blood cells called B lymphocytes.