Shire plc : New Formulation of ONCASPAR® (pegaspargase) Receives Positive CHMP Opinion in Europe for Patients with Acute Lymphoblastic Leukemia (ALL)

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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. 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.

"Lyophilized ONCASPAR builds on more than a decade of data and research with liquid ONCASPAR, and with no change in dosing regimen, it offers a three-times longer shelf life," said Howard B. Mayer, M.D., SVP and ad-interim Head, Global Research and Development, Shire. "Prolonging shelf life to 24 months for this critically-important therapy facilitates management of product inventory by enabling greater flexibility and longer-term planning. Once approved, with the extended shelf life of lyophilized ONCASPAR, we also hope to improve access to the medicine for ALL patients in countries currently not offering liquid ONCASPAR."

Lyophilized ONCASPAR works the same way as the liquid formulation by rapidly depleting serum L-asparagine levels and interfering with protein synthesis, thereby depriving lymphoblasts of asparaginase and resulting in cell death. That is why asparaginase is a critical component of the treatment regimen for ALL patients as it is a proven approach to inducing leukemic cell death.4

ONCASPAR can be given by intramuscular injection or intravenous infusion. For smaller volumes of ONCASPAR, the preferred route of administration is intramuscular. When ONCASPAR is given by intramuscular injection the volume injected at one site should not exceed 2 ml in children and adolescents and 3 ml in adults. If higher volume is given, the dose should be divided and given at several injection sites. Intravenous infusion of ONCASPAR is usually given over a period of 1 to 2 hours in 100 ml sodium chloride 9 mg/ml (0.9%) solution for injection or 5% glucose solution. The diluted solution of ONCASPAR can be given together with an already-running infusion of either sodium chloride 9 mg/ml or 5% glucose. Do not infuse other medicinal products through the same intravenous line during administration of ONCASPAR.

Anaphylaxis or serious allergic reactions can occur; therefore, patients should be observed for 1 hour after administration having resuscitation equipment ready. Discontinue ONCASPAR in patients with serious allergic reactions. There have been reports of adverse reactions of pancreatitis. If pancreatitis is suspected ONCASPAR should be discontinued. ONCASPAR should also be discontinued in patients with serious thrombotic events.

Combination therapy with ONCASPAR can result in hepatic toxicity and central nervous system toxicity. Appropriate monitoring should be performed for liver impairment, blood and urine glucose levels as well as serum amylase for early signs of inflammation of the pancreas.

Very common adverse reactions reported in clinical trial data and the post-marketing experience of ONCASPAR in ALL patients include: hyperglycemia, pancreatitis, diarrhea, abdominal pain, nausea, vomiting, stomatitis, hypersensitivity, urticaria, anaphylactic reaction, weight decreased, decreased appetite, and rash.

Common adverse reactions include: febrile neutropenia, anemia, coagulopathy, hepatotoxicity, fatty liver, infections, sepsis, amylase increased, alanine aminotransferase increased, blood bilirubin increased, blood albumin decreased, neutrophil count decreased, platelet count decreased, activated partial thromboplastin time prolonged, prothrombin time prolonged, hypofibrinogenemia, hypertriglyceridemia, hyperlipidemia, hypercholesterolemia, pain in extremities, seizure, peripheral motor neuropathy, syncope, posterior reversible leukoencephalopathy syndrome, hypoxia, and thrombosis.1

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

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Globe Newswire: 07:05 GMT Friday 13th October 2017

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