On December 13, 2017 Shire plc (LSE: SHP, NASDAQ: SHPG), the global leader in rare diseases, reported that the European Commission (EC) granted 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 (Press release, Shire, DEC 13, 2017, View Source [SID1234522624]).1 The approval – which authorizes Shire to market lyophilized ONCASPAR in the 28 member states of the European Union (EU), as well as Iceland, Liechtenstein and Norway – follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) on October 12.
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"This approval underscores Shire’s commitment to patients with acute lymphoblastic leukemia through continued research and evolution of asparaginase therapy," said Howard B. Mayer, M.D., SVP and ad-interim Head, Global Research and Development, Shire. "With this lyophilized formulation, we aim to make pegylated asparaginase, part of the pediatric standard therapy in acute lymphoblastic leukemia, available to patients in countries where liquid ONCASPAR is not currently offered. Additionally, with extended shelf life up to 24 months, treatment centers will have flexibility in inventory management to help ensure continuous treatment supply for patients."
Lyophilized ONCASPAR builds on more than a decade of data and research with liquid ONCASPAR, a pegylated asparaginase, and works the same way as the liquid formulation. By depleting serum L-asparagine levels and thereby interfering with protein synthesis, ONCASPAR deprives lymphoblasts of L-asparagine, resulting in cell death.2,3,4
The new lyophilized formulation offers the same dosing regimen as liquid ONCASPAR, but with a three-times longer shelf life than the liquid formulation.1 Asparaginase is a critical component of the treatment regimen for ALL patients as it is a proven approach to inducing leukemic cell death.2,3,4
Shire expects lyophilized ONCASPAR to be available in European markets beginning in the first half of 2018.
About Acute Lymphoblastic Leukemia
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 leukemia5. ALL can be curable within certain pediatric patient populations, with a five-year overall survival rate of 96% in children treated with regimens including ONCASPAR6.