FDA approves use of Imbruvica to treat patients with chronic lymphocytic leukemia

FDA approves use of Imbruvica to treat patients with chronic lymphocytic leukemia -

The Food and Drug Administration of the United States today expanded the use approved Imbruvica (Ibrutinib) to treat patients with chronic lymphocytic leukemia (CLL) which carry a deletion in chromosome 17 (17p deletion), which is associated with poor response to standard treatment for CLL. Imbruvica received a breakthrough therapy designation for this use.

The FDA also approved new labeling to indicate the Imbruvica clinical benefit in CLL treatment was verified. In February 2014, Imbruvica received accelerated approval to treat CLL based on its effect on the overall response rate. New results from clinical trials examining the progression-free survival and overall survival confirmed the clinical benefit of the drug.

One type of non-Hodgkin lymphoma, CLL is a disease of the rare bone marrow blood and bone that usually gets worse slowly over time, causing a gradual increase in the number of white blood cells, lymphocytes B cells or B. the National cancer Institute estimates that 15.720 Americans will be diagnosed and 4,0 will die of CLL in 2014. Imbruvica works by blocking the enzyme that allows cancer cells to grow and divide.

"We continue to see progress in the availability of therapies to treat chronic lymphocytic leukemia, especially for people in difficult to treat patients," said Richard Pazdur, MD, director of the Office of Hematology and oncology Products in the FDA's Center for evaluation and drug research. "Imbruvica is the fourth drug approved to treat CLL who received a breakthrough therapy designation, reflecting the promise of advanced therapy designation program and demonstrate the commitment of the FDA to work collaboratively with companies to speed the development, review and approval of these important new medicines. "

the other three drugs approved to treat CLL who received the breakthrough designations are Gazyva (obinutuzumab) in November 2013, Arzerra ( ofatumumab) in April 2014 and Zydelig (idelalisib) in July 2014. the request for accelerated approval Imbruvica to treat CLL has received advanced therapy appointment.

approval for Imbruvica actions today are based on a clinical study of 391 previously untreated participants, 127 of them had CLL with 17p deletion. Participants were randomized to receive Arzerra Imbruvica or until progression or side effects of the disease has become intolerable.

participants treated Imbruvica

The trial was stopped early for efficacy after a pre-planned interim analysis showed experienced a reduction of 78 percent in the risk of disease progression or death (survival without progression). The results also showed a reduction of 57 percent the risk of death (overall survival) in participants treated with Imbruvica. Of the 127 participants who had CLL with 17p deletion, those treated with Imbruvica experienced a 75 percent risk of disease progression or death.

The most common side effects associated with Imbruvica observed in the clinical study include low levels of platelets in the blood (thrombocytopenia), reduced infection-fighting cells called neutrophils white blood cells (neutropenia) , diarrhea, low red blood cells (anemia), tiredness, pain in the muscles and bones (musculoskeletal pain), upper respiratory tract infection, rash, nausea and fever (pyrexia) .

new use Imbruvica approved more than two months before the drug user prescription Date object fresh product of 7 October 2014, the date the FDA was expected to complete consideration of the demand for drugs . The FDA reviewed the application of Imbruvica for this new use in the review program of the Agency's priorities, which provides for an expedited review of drugs intended to treat a serious disease or condition, and, if approved, would offer a significant improvement compared to marketed products.

Imbruvica also received accelerated approval in November 2013 for the treatment of patients with mantle cell lymphoma who have received at least one prior therapy. Clinical studies to verify and describe the clinical benefit of Imbruvica in lymphoma mantle cell are underway.

Imbruvica is co-marketed by Pharmacyclics, based in Sunnyvale, Calif., And Janssen Biotech, based in Horsham, Penn.

The FDA, an agency of the US Department of Health and Human Services, protects the public health by ensuring the safety, efficacy and security of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety and security of supply of our nation food, cosmetics, dietary supplements, products that emit an electron beam and regulation of tobacco products.