Clipping of news on Brazilian Culture, Law and Citizenship
05/11/2012
This article was translated by an automatic translation system, and was therefore not reviewed by people.
Synribo is indicated for use in adults with advanced cancer after treatment with at least two other medications
The Food and Drug Administration (FDA) approved the drug Synribo (omacetaxine mepesuccinate) to treat adults with chronic leukemia oide miel (CML), a disease that attacks the blood and bone marrow.
It is estimated that 5430 people will be diagnosed with CML in 2012, according to the National Institutes of Health. Synribo intended to be used in patients with advanced cancer, after treatment with at least two medications of a class called tyrosine kinase inhibitor (TKI), also used to hold the disease.
Synribo blocks certain proteins which promote the development of cancer cells. It is injected under the skin (subcutaneously), twice daily for 14 consecutive days over a 28 day cycle until the white blood cell counts normalized. The drug is then administered twice daily for seven consecutive days over a 28 day cycle, while patients continue to benefit from therapy clinically.
"This approval provides a new treatment option for patients who are resistant to or can not tolerate other FDA approved drugs for chronic or accelerated phase of the disease. Synribo is the second drug approved for the treatment of leukemia for the past two mese" said Richard Pazdur, FDA.
The effectiveness of Synribo was evaluated using a combined group of patients whose cancer has progressed following treatment with two or more tyrosine kinase inhibitors. All participants were treated Synribo.
The efficacy of the drug in chronic phase was demonstrated by a reduction in the percentage of cells expressing a genetic mutation found in most patients with the disease. Fourteen of 76 patients (18.4%) achieved this reduction in an average time of 3.5 months. The duration of the reduction was 12.5 months.
In the accelerated phase, the effectiveness of Synribo was determined by the number of patients experiencing a normalization in white blood cell count or no evidence of leukemia (major hematologic response, or MaHR). The results showed that five of the 35 patients (14.3%) obtained in MaHR an average of 2.3 months. The average duration of MaHR these patients was 4.7 months.
The most common side effects reported in clinical studies include low level of blood platelets (thrombocytopenia), low count of red blood cells (anemia), decrease in immune cells, diarrhea, nausea, weakness and fatigue.
Source: R7 News
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This article was translated by an automatic translation system, and was therefore not reviewed by people.