Experimental Drug Turns Off Leukemia Cells

Medical experts say every year about 12,000 patients in the U.S. are diagnosed with chronic lymphocytic leukemia. But a new drug has shown promise for patients who've 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 can do my job, I sell houses,” says Dennis Hickey who has chronic lymphocytic leukemia. “I can enjoy the grandkids."

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

"The prognosis was not good," says Dennis.

With six months to live, Dennis got to take an experimental drug called ibrutinib as part of a clinical trial for CLL patients.

"We've 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," explains Dr. John C. Byrd, MD, D. Warren Brown Chair of Leukemia Research at the Ohio State University Comprehensive Cancer Center.

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.

"Patients tolerate it very, very well,” says Dr. Byrd. “Many patients will say they feel like they did before they had CLL."

Researchers say ibrutinib's a game changer. Dennis Hickey says it's a life saver.

"I'm still here,” explains Dennis. “I look, I look back to it and say boy, I've been blessed, and I'm so thankful."

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.


TOPIC: Experimental Drug Turns Off Leukemia Cells
REPORT: MB# 3670

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)


The Ohio State University

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