BTG debuts Voraxaze in the USA

The US subsidiary of the UK-based BTG (LSE: BGC) yesterday announced the launch of Voraxaze (glucarpidase) in the USA. Voraxaze, which was approved by the Food and Drug Administration earlier this year (The Pharma Letter January 19), is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function.

Voraxaze breaks down methotrexate into inactive metabolites which are then eliminated from the body by routes other than the kidney (primarily the liver). Voraxaze is the first and only drug available to reduce toxic plasma methotrexate levels. High dose methotrexate chemotherapy is used to treat or prevent the recurrence of certain cancers, including osteosarcoma, and certain leukemias, and lymphomas.

Some patients treated with high dose methotrexate develop impaired kidney function, which leads to the accumulation of toxic levels of methotrexate in the blood resulting in clinical manifestations of toxicity. The most common related adverse events in clinical trials were paresthesia (a sensation of tingling or burning on the skin), flushing, nausea, vomiting, hypotension and headache.