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Experimental Drug Turns Off Leukemia Cells

From a death sentence to a second chance at life.
Medical experts say every year about 12,000 patients in the United States are diagnosed with chronic lymphocytic leukemia, but a new drug has shown promise for patients who have lost all hope of beating the disease.

It's the simple things, like enjoying the outdoors and taking family vacations that 73 year old Dennis Hickey can look forward to once again.

"I'm very fortunate, I'm excited about life.  I can do my job, I sell houses, I can enjoy the grandkids," Hickey told Ivanhoe.

Hickey has chronic lymphocytic leukemia, or CLL, a common and deadly form of leukemia affecting older adults. 

"The prognosis was not good, but I was going to see it through no matter what," Hickey said.

With six months to live, Hickey got to take an experimental drug called Ibrutinib as part of a clinical trial for CLL patients.  John Byrd, MD, and professor of medicine at the Ohio State University, co-led the study.

"We have seen a drug come into the clinic that has really helped patients with CLL and related diseases that have been at the end of their life," Dr. Byrd explained.

The drug works by targeting the protein in CLL cells. Without the protein, the cancer can't grow.  Doctors say 90 percent of patients have had success with Ibrutinib and side effects are minimal compared to chemotherapy.

"The patients tolerate it very, very well. Many patients say they feel like they did before they had CLL," Dr. Byrd said.

Researchers say Ibrutinib is a game-changer. Hickey says it's a life-saver. 

"I'm still here and I'm so thankful," Hickey said.

Researchers say Ibrutinib is not a cure, but if patients follow treatment, they can manage CLL the same way they would manage diabetes or high blood pressure.

The drug is expected to be approved by the FDA in early 2014.

BACKGROUND: Chronic lymphocytic leukemia (CLL) is a type of cancer of the blood and bone marrow. The term "chronic" comes from the fact that it typically progresses more slowly than other types of leukemia  and "lymphocytic" comes from the cells affected by the disease — a group of white blood cells called lymphocytes, which help your body fight infection.  (SOURCE: http://www.mayoclinic.com/health/chronic-lymphocytic-leukemia)

SYMPTOMS: Many people with CLL have no early symptoms. Those who develop signs and symptoms may experience:
•Enlarged, but painless, lymph nodes
•Pain in the upper left portion of the abdomen, which may be caused by an enlarged spleen
•Frequent infections
(SOURCE: http://www.mayoclinic.com/health/chronic-lymphocytic-leukemia)

TREATMENT: A new drug application has been submitted to the FDA for the investigational agent Ibrutinib as a therapy for previously treated chronic lymphocytic leukemia (CLL) and previously treated mantle cell lymphoma (MCL) after the positive results observed in two clinical trials, which showed high response rates to the drug.

The filing for the indication for CLL was based on the results of a phase Ib/II trial, in which 85 patients with relapsed or refractory CLL or small lymphocytic lymphoma (SLL) received Ibrutinib orally once daily, with 51 patients receiving a 420 mg dose and 34 patients receiving an 840 mg dose.

The overall response rate (ORR) in both treatment groups was 71%, with an additional 20% of patients in the 420 mg dose arm and 15% of patients in the 840 mg dose arm experiencing a partial response with lymphocytosis. After 26 months of follow-up, the estimated rate of progression-free survival (PFS) was 75%, and the rate of overall survival (OS) was 83% for all patients, irrespective of the dose. Side effects were minimal and consisted mostly of grade 1 or 2 transient diarrhea, fatigue, and upper respiratory tract infection. (SOURCE: http://www.onclive.com/web-exclusives/NDA-Filed-for-Ibrutinib-in-CLL-and-MCL)

FOR MORE INFORMATION, PLEASE CONTACT:

The Ohio State University
614-293-9869

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