CHMP recommends lyophilized Oncaspar (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in pediatric patients.- Shire plc.
Shire plc announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the marketing authorization for lyophilized Oncaspar (pegaspargase), as a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in pediatric patients from birth to 18 years, and in adult patients.
Lyophilized Oncaspar is a freeze-dried formulation of Oncaspar. The liquid form of Oncaspar is currently approved for the same indication in ALL, and is part of the pediatric standard therapy in ALL in many European countries. The CHMP's positive opinion will be submitted to the European Commission (EC), which is responsible for granting marketing authorizations for medicines in the EU.
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