On November 23, 2015 Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for use of ONCASPAR as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients (Press release, Baxalta, NOV 23, 2015, View Source [SID:1234508319]). Schedule your 30 min Free 1stOncology Demo! The CHMP’s positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union. Pending EC approval, Baxalta will be authorized to market ONCASPAR in the 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein and Norway.
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Pending EC approval, ONCASPAR will provide an important treatment option for more European patients with this rapidly progressing cancer of the white blood cells responsible for more than 80 percent of childhood leukaemia cases2 – the most common type of childhood cancer.
"We are pleased to receive a positive CHMP opinion for ONCASPAR as part of a multi-agent chemotherapy regimen in paediatric and adult populations; this is a significant milestone in increasing patient access to this important biologic treatment for patients impacted by ALL," said John Orloff, M.D., head of Research & Development and chief scientific officer, Baxalta. "At Baxalta, we are committed to expanding the availability of ONCASPAR globally, and this decision makes a curative treatment available to more patients across the world."
Today, children in the U.S. diagnosed with ALL have a survival rate of more than 90 percent – a direct result of multi-agent chemotherapy treatments. ONCASPAR is a key component of these curative therapies. Currently, there have been national licenses granted to market ONCASPAR in Argentina, Belarus, Germany, Kazakhstan, Poland, Russia, Ukraine and the United States.
About ONCASPAR (pegaspargase)
In the U.S., ONCASPAR (pegaspargase) is indicated as a component of a multi-agent chemotherapeutic regimen for the first–line treatment of patients with acute lymphoblastic leukaemia (ALL) and for the treatment of patients with ALL and hypersensitivity to native forms of L-asparaginase.
Important Safety Information for ONCASPAR
ONCASPAR is contraindicated in patients with a history of serious allergic reactions to pegaspargase, and in patients with a history of pancreatitis, serious thrombosis, or serious hemorrhagic events with prior L-asparaginase therapy.
The most common adverse reactions with ONCASPAR (=2%) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) events, thrombosis, coagulopathy, hyperbilirubinemia, and elevated transaminases. Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to ONCASPAR.
Patients should be observed for one hour after administration as anaphylaxis or serious allergic reactions can occur. Discontinue ONCASPAR in patients that develop pancreatitis, serious allergic reactions, or serious thrombotic events. Patients with abdominal pain should be evaluated for evidence of pancreatitis.
Serum glucose should be monitored as irreversible glucose intolerance can occur in some cases. Coagulopathy and hepatotoxicity can occur; appropriate monitoring should be performed.
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About Acute Lymphoblastic Leukaemia
Acute lymphoblastic leukaemia (ALL) is a rare, fast-growing cancer of the white blood cells, and each year there are approximately 4,000-5,000 new cases in Europe and the United States, respectively. The disease is the most common childhood cancer and is responsible for more than 80 percent of childhood leukaemia cases. The five-year paediatric survival rate has climbed to 90 percent with modern therapies.