The US Food and Drug Administration today approved the Biologics License Application by manufacturer BTG for Voraxaze (glucarpidase).
Voraxaze is an enzyme that helps patients who are receiving the chemotherapy drug methotrexate by breaking the drug down into smaller, more easily cleared by-products. In some patients, plasma concentrations of methotrexate can rise to toxic levels because of impaired renal function, leading to a number of difficult side effects, such as organ damage, mouth sores, damage to the lining of the intestine, rashes, and in some cases even death
Methotrexate is one of the oldest chemotherapy drugs on the market, and is used against a wide range of cancers, including hematologic cancers, lung cancer, breast cancer, head and neck cancer, bladder cancer, and several others. It also has medical uses beyond cancer.
Voraxaze is administered intravenously. Side effects included hypotension, headache, and nausea/vomiting.
Source: US FDA
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The actual FDA report says:
The actual FDA report says:
"A single clinical study of 22 patients evaluated the effectiveness of Voraxaze. All patients received Voraxaze treatment. 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 this result, Voraxaze eliminated 95 percent of the methotrexate in all patients. A separate clinical study evaluated the safety of Voraxaze in 290 patients experiencing problems clearing methotrexate from their blood."
That actual clinical study says this: Among the 290 patients included in the safety evaluation of VORAXAZE, there were 8 deaths within 30 days of VORAXAZE exposure that were not related to progressive disease. Twenty-one of 290 patients (7%) experienced adverse reactions that were assessed as related to VORAXAZE." Furthermore "There are no controlled trials comparing VORAXAZE plus supportive care to supportive care measures alone in patients with toxic plasma methotrexate concentrations due to impaired renal function, therefore there are no data regarding the effect of VORAXAZE on survival or toxic deaths due to methotrexate."
Essentially the FDA needs to be a little more transparent with their information. The FDA is a great start, but do your own research.