The U.S. Food and Drug Administration has approved the use of the intravenous drug TRISENOX (Teva Pharmaceutical Industries Ltd.) in combination with tretinoin for first line treatment of adult patients who have been newly-diagnosed with low-risk acute promyelocytic leukemia. The approval reinforces current practice guidelines from the National Comprehensive Cancer Network, according to a press release.
TRISENOX (arsenic trioxide) is an injectable drug that is indicated for the treatment of patients with APL who “are refractory to, or have relapsed from, retinoid and anthracycline chemotherapy” and whose “APL is characterized by the presence of the t(15;17) translocation or PML/RAR-alpha gene expression”, according to CenterWatch, a drug information website.
Injectable. (Source: Flickr)
Teva Pharmaceuticals provided information on adverse events experienced by patients with APL. The company warns that patients with APL have experienced symptoms of differentiation syndrome, which can be fatal, and cardiac conduction abnormalities as well as QT interval prolongation.
One study published in the Blood journal found that from the drug’s initial approval in 2000 to July 2016, there were a total of 2197 reported adverse events associated with arsenic trioxide in patients with APL. Out of those reports, 1735 were classified as “serious” and 462 reports were classified as “nonserious”.
The serious adverse events, including cardiac disorders such as ventricular tachycardia, were associated with QT prolongation. Other adverse events that occurred were neutropenia, leukocytosis, liver toxicity, pancytopenia, cardiac disorders, and a decrease in white blood cells.
The FDA is expected to release their decision on the drug’s supplemental application this year.