(RxWiki News) The medication Gleevec (imatinib) remains the standard of care for people newly diagnosed with chronic myeloid leukemia (CML). But not all patients respond well to this medicine, and now they have an alternative.
Sprycel (dasatinib) works well for patients with CML who either do not respond to or have become resistant to Gleevec. These are the findings of a five-year follow-up study of an ongoing trial measuring the effectiveness and safety of Sprycel to treat chronic (earliest) phase CML.
"Sprycel treats chronic phase CML when Gleevec no longer works."
The trial that's known as Study CA180-034 is looking specifically at once-daily Sprycel 100 mg to treat chronic phase CML (CP-CML). A total of 670 CP-CML patients who were either intolerant or resistant to Gleevec are enrolled.
Participants were randomly assigned to one of four groups taking different dosages of Sprycel - 100 mg once daily, 50 mg twice daily, 140 mg once daily, 70 mg twice daily.
To date, the study has found that overall survival among those receiving the once daily 100 mg regimen of Sprycel was 78 percent and progression-free survival was 57 percent. In five percent of patients receiving this dosage, the disease got worse - progressing to the accelerated or blastic stage.
Participants tolerate the medication well, according to the study authors.
Neil Shah, M.D., Ph.D., Assistant Professor in the Division of Hematology/Oncology at the University of California, San Francisco and principal investigator of the study, says these findings show that Sprycell is an effective and safe therapy for long-term use by patients who don't do well with Gleevec.
These findings were presented at 47th Annual Meeting of the American Society of Clinical Oncology. Research findings are considered preliminary until they are pubished in a peer-reviewed journal.
Sprycel has received full approval from the U.S. Food & Drug Administration (FDA) to treat all phases of CML in 2009. Today, it is approved for this use in 60 countries worldwide.