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news.Baxalta has secured approval from the European Commission (EC) for its Oncaspar (pegaspargase) as a component of combination chemotherapy in pediatric and adult patients with acute lymphoblastic leukemia (ALL).
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In November last year, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval for Oncaspar.
Baxalta said the EC’s marketing authorization for Oncaspar will provide a crucial treatment option for more European patients with the rapidly progressing cancer of the white blood cells accounting for about 80 % of childhood leukaemia cases.
ALL also occurs in adults, responsible for around 40% of the annual incidence.
The most common adverse reactions with Oncaspar are allergic reactions including anaphylaxis, hyperglycemia, pancreatitis, central nervous system toxicity, thrombosis, coagulopathy, hyperbilirubinemia and elevated transaminases.
Baxalta executive vice president and president of oncology David Meek said: "For more than two decades, Oncaspar has fulfilled a clear need for an effective and well-tolerated treatment for ALL patients worldwide.
"This European marketing authorization allows Baxalta to expand the use of ONCASPAR, improving treatment outcomes for all patients in the EU."
ALL is a rare blood cancer that affects about 4,000 to 5,000 people per year in Europe and the US.
The five-year paediatric survival rate has increased to over 80% with modern therapies.