Baxalta Incorporated, a global biopharmaceutical leader, announced that the European Commission has granted Marketing Authorisation for use of Oncaspar as a combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.
With this approval, Baxalta is authorised to market Oncaspar in the 28 member countries of the European Union (EU), as well as Iceland, Liechtenstein and Norway. The drug is already licensed to market in Argentina, Belarus, Germany, Kazakhstan, Poland, Russia, Ukraine and the United States.
“Oncaspar has been used as an integral component of the treatment regimen for paediatric and adult patients with ALL for many years, in Europe, and worldwide,” said Prof. Dr. med. Martin Schrappe, director of the department of general paediatrics at the Schleswig-Holstein University Hospital in Kiel, Germany.
“Today’s marketing authorisation will ensure that more patients across the EU will benefit from access to Oncaspar as part of a standard of care regimen.”
With this authorisation, Oncaspar will provide an important treatment option for more European patients with this rapidly progressing cancer of the white blood cells responsible for up to 80 percent of childhood leukaemia cases - the most common type of childhood cancer. However, ALL is not only a childhood cancer but can also occur in adults. Adult ALL accounts for approximately 40 per cent of the annual incidence.
"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 authorisation allows Baxalta to expand the use of Oncaspar, improving treatment outcomes for all patients in the EU,” said David Meek, executive vice president and president, oncology, Baxalta. “This approval is important as we strive to make a difference in the lives of people living with cancer in all parts of the world."
Oncaspar is contraindicated in patients with severe hepatic impairment (defined as bilirubin > 3 times upper limit of normal [ULN]; transaminases > 10 times ULN), a history of serious thrombosis with prior L asparaginase therapy, a history of pancreatitis, including the related to previous asparaginase therapy and those with a history of serious hemorrhagic events with prior L asparaginase therapy.
The most common adverse reactions with Oncaspar (=2 per cent) are allergic reactions (including anaphylaxis), hyperglycemia, pancreatitis, central nervous system (CNS) toxicity, thrombosis, coagulopathy, hyperbilirubinemia and elevated transaminases. Hyperlipidemia (hypercholesterolemia and hypertriglyceridemia) has been reported in patients exposed to Oncaspar.
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 more than 80 per cent with modern therapies.