FDA Approves Voraxaze To Treat Patients With Chemotherapy Toxicity

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Main Category: Cancer / Oncology
Article Date: 17 Jan 2012 - 17:00 PST
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Voraxaze is an enzyme that rapidly breaks down the chemotherapy drug methotrexate to a byproduct that the body can more easily eliminate. Voraxaze is given intravenously.
Methotrexate was developed in the 1950s as a chemotherapy and is used either alone or in combination with other drugs. It is effective for the treatment of a number of cancers including: breast, head and neck, leukemia, lymphoma, lung, osteosarcoma, bladder, and trophoblastic neoplasms. It is also used for autoimmune diseases such as rheumatoid arthritis, psoriasis, psoriatic arthritis, lupus and Crohn's disease, as well as for treating ectopic pregnancy and for inducing medical abortions.
Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research said :

"Prolonged exposure to high levels of methotrexate can result in kidney and liver damage, severe mouth sores, damage to the lining of the intestine, skin rashes, and death due to low blood counts ... Voraxaze is an important new treatment option for cancer patients aimed at preventing these toxicities associated with sustained high levels of methotrexate."

22 patients were added to a single clinical trial aiming to evaluate the effectiveness of Voraxaze. All the patients received Voraxaze treatment and the study considered treatment a success if the methotrexate level fell below a critical level within 15 minutes and stayed below the critical level for eight days. Ten of the 22 patients achieved this standard. Although not all patients experienced the highest results, Voraxaze eliminated 95 percent of the methotrexate in all patients. A separate trial of 290 patients analyzed problems of clearing the drug from the bloodsteam
Patients did complain of some side effects including : low blood pressure (hypotension), headache, nausea, vomiting, flushing, and abnormal sensation (paraesthesia) which were experienced by around one percent of test subjects.
Written by Rupert Shepherd
Copyright: Medical News Today
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