Relief is now available to patients with two forms of leukemia who have not responded to other treatments. The US Food and Drug Administration has approved Sprycel (dasatinib) for people with chronic myeloid leukemia (CML) who are resistant to Gleevec or can't tolerate the drug, and for people with Philadelphia chromosome-positive acute lymphocytic leukemia (ALL) who are no longer being helped by their treatment.
Sprycel is made by Bristol-Myers-Squibb. The treatment is generally available throughout the US as a tablet to be taken twice daily.
Doctors associated with Cancer Research and Treatment Fund (CR&T), including Medical Director. Dr. Richard Silver, participated in the clinical trials held over the last two years at the Weill Cornell Medical College. CR&T provided partial funding through the William Waugh and Judy Olin Higgins Center for the Study of Leukemia and Myeloproliferative Diseases.
Classified as an orphan disease, CML will strike about 4,500 people in 2006 and, though at one time considered universally fatal, will kill about 600. The pill Gleevec is very effective for CML and has helped many people live longer with this disease. However, some people cannot tolerate the drug, and others eventually develop resistance to it.
ALL is also uncommon. Nearly 3,930 new cases and 1,490 deaths are expected in the US in 2006. Philadelphia chromosome-positive ALL is a more serious form of the disease, and people who have it typically develop treatment resistance sooner.
Now, people in these situations have another treatment they can try. Sprycel is a targeted therapy that works by blocking the activity of proteins that cause leukemia cells to grow.
In national clinical trials of more than 400 people who could no longer take Gleevec, about 45% of people with early stages of CML had a positive response to the drug, meaning they had either no detectable leukemia cells in their blood after treatment, or a significant reduction in the number of leukemia cells. For people with more advanced CML and with ALL, the response rates ranged from 31% to 59%, the FDA said.
Side effects from the new drug may include fluid retention, bleeding, diarrhea, skin rashes, infections, headaches, fatigue, and nausea. It can also cause anemia, low white blood cell counts, and low platelet counts.
###