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FDA approves new leukemia treatment dasatinib (Sprycel)From MayoClinic.com
Special to CNN.com
What happened? People with certain rare blood cancers now have a new treatment option if other treatments have failed.
The Food and Drug Administration (FDA) has approved dasatinib (Sprycel) for people with chronic myelogenous leukemia (CML) and for those with a certain type of acute lymphocytic leukemia (ALL) called Philadelphia chromosome-positive ALL. This new leukemia treatment is a targeted therapy that may give hope to people for whom imatinib (Gleevec) no longer works or for those who never had success with the drug.
Dasatinib is a leukemia treatment that works by blocking certain growth signals that cancer cells give off to fuel their development. The FDA analyzed data from four clinical studies of dasatinib that showed the leukemia treatment reduces the number of leukemia cells found in the blood and bone marrow. However, more study of this new leukemia treatment is needed to determine whether it's able to prolong the lives of people with these leukemias.
Dasatinib comes in tablet form. Side effects include low blood counts (myelosuppression), which can lead to bleeding, infection and fatigue. Other side effects include fluid retention, headache, skin rash and nausea.
What does this mean to you? Dasatinib is approved as a leukemia treatment only for people who've already tried imatinib. If imatinib has stopped working for you, if it never worked or if you're unable to tolerate its side effects, you and your doctor may consider this new leukemia treatment.
Dasatinib has been given accelerated approval by the FDA — meaning that more studies are needed to fully understand what this drug can do and what side effects it may cause. Other studies are under way to gather more information. While early results are promising, there's no proof yet that dasatinib can extend the lives or improve the quality of life of people with CML or ALL.
Discuss your options with your doctor to decide whether dasatinib is an appropriate treatment option for you.
June 30, 2006