Those who have a type of cancer called chronic myeloid leukemia (CML) may receive Synribo after at least two other medications have been tried. This prescription chemotherapy drug is used when the cancer has become worse or when the prior treatment could not be tolerated. It is given as an injection just under the skin. Side effects include diarrhea, fatigue, and anemia.
Synribo is used in people who have already received at least two medications in a class of drugs known as tyrosine kinase inhibitors. It is recommended when the leukemia has progressed, despite the other treatment, or when the treatment could not be tolerated.
Synribo is manufactured by Teva Pharmaceuticals, USA, Inc.
Synribo was studied in clinical trials that included people with CML who had previously been treated with at least two tyrosine kinase inhibitors but did not tolerate the medications or did not adequately respond to them. In these studies, 18.4 percent of people with chronic-phase CML, on average, had a major cytogenetic response, meaning 35 percent or less of cells tested positive for the Philadelphia chromosome (a genetic abnormality found in most people with CML).
It took a median of 3.5 months for this reduction in leukemia cells to occur (the median is the middle number, meaning half of the people responded within 3.5 months, while the other half took longer than 3.5 months). The reduction in leukemia cells lasted a median of 12.5 months.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Synribo [package insert]. North Wales, PA: Teva Pharmaceuticals USA, Inc.;2012 October.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed March 11, 2013.
Food and Drug Administration (FDA) news release. FDA approves Synribo for chronic myelogenous leukemia. Available at http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm325895.htm. Accessed November 12, 2012.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed November 12, 2012.
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