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Find Clinical Drug Pipeline Developments & Deals for Glucarpidase
M8 will register, market and commercialize SERB's supportive oncology product Voraxaze (glucarpidase), a carboxypeptidase that reduces toxic plasma methotrexate concentration, in Latin America.
Company recieved positive opinion of CHMP of Voraxaze® (glucarpidase) based on clinical data and real world experience. Voraxaze reduces toxic plasma methotrexate concentration in adults and children may quickly lower MTX levels and avoid further systemic damage.
Voraxaze® is a carboxypeptidase indicated to reduce toxic plasma methotrexate concentration (greater than 1 micromole per liter) in adult and pediatric patients with delayed methotrexate clearance due to impaired renal function.
An ongoing arm of the study triggered by the difficult circumstances created by the COVID-19 pandemic is exploring the planned use of Voraxaze® (glucarpidase) to enable high dose MTX treatment of CNSL on an outpatient basis.
In this study, adult patients with isolated CNSL are treated with rituximab and methotrexate administered for eight cycles. Voraxaze® is given 24 hours following start of each methotrexate infusion.