SAINT HELIER (dpa-AFX) - Shire plc (SHPG, SHP.L) said that the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or 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 or 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.1 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.
Acute lymphoblastic leukemia (ALL) is a cancer of the white blood cells and is characterized by an overproduction and accumulation of lymphoblasts, immature white blood cells. ALL is the most common type (~75%) of cancer among children diagnosed with leukemia.2 ALL can be curable within certain pediatric patient populations, with a 5-year survival rate of more than 90% in children treated with regimens including ONCASPAR.
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