Baxalta Granted EU Marketing Authorization For ONCASPAR (Pegaspargase) As A Component Of Combination Therapy In Acute Lymphoblastic Leukaemia (ALL)

BANNOCKBURN, Ill.--(BUSINESS WIRE)--Baxalta Incorporated (NYSE:BXLT), a global biopharmaceutical leader dedicated to delivering transformative therapies to patients with orphan diseases and underserved conditions, today announced that the European Commission has granted Marketing Authorization 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 authorized 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 authorization will ensure that more patients across the EU will benefit from access to ONCASPAR as part of a standard of care regimen.”

With this authorization, 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 percent of the annual incidence.²

"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,” 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."

About ONCASPAR (pegaspargase) in the EU

ONCASPAR is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.³

Contraindications³

• Hypersensitivity to the active substance or to any of the excipients
• Severe hepatic impairment (bilirubin > 3 times upper limit of normal [ULN]; transaminases > 10 times ULN)
• History of serious thrombosis with prior L-asparaginase therapy
• History of pancreatitis, including the related to previous asparaginase therapy
• History of serious hemorrhagic events with prior L-asparaginase therapy

EU Important Safety Information

ONCASPAR is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia (ALL) in paediatric patients from birth to 18 years, and adult patients.

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.

Anaphylaxis or serious allergic reactions can occur; therefore, patients should be observed for one hour after administration. Discontinue ONCASPAR in patients with serious allergic reactions. Patients with abdominal pain should be evaluated for evidence of pancreatitis. Discontinue ONCASPAR in patients with pancreatitis. ONCASPAR should also be discontinued in patients with serious thrombotic events.

Glucose intolerance, in some cases irreversible, can occur; serum glucose should be monitored. Coagulopathy and hepatotoxicity can occur; appropriate monitoring should be performed.

The most common adverse reactions with ONCASPAR (=2%) 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.

Oncaspar may possess immunosuppressive activity. It is therefore possible that use of this medicinal product promotes infections in patients.

Combination therapy with Oncaspar can result in severe hepatic toxicity and central nervous system toxicity. Caution is required when Oncaspar is given in combination with other hepatotoxic substances, especially if there is preexisting hepatic impairment. In this case, patients should be monitored for liver impairment.

In the presence of symptoms of hyperammonemia (e.g. nausea, vomiting, lethargy, irritation), ammonia levels should be monitored closely.

Labeling may differ by country registration. Please refer to your country specific labeling for detailed information.

About Acute Lymphoblastic Leukaemia¹

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 more than 80 percent with modern therapies.

About Baxalta

Baxalta Incorporated (NYSE: BXLT) is a $6 billion global biopharmaceutical leader developing, manufacturing, and commercializing therapies for orphan diseases and underserved conditions in hematology, oncology and immunology. Driven by passion to make a meaningful impact on patients’ lives, Baxalta’s broad and diverse pipeline includes biologics with novel mechanisms and advanced technology platforms such as gene therapy. The Baxalta Global Innovation and R&D Center is located in Cambridge, Massachusetts. Launched in 2015 following separation from Baxter International, Baxalta’s heritage in biopharmaceuticals spans decades. Baxalta’s therapies are available in more than 100 countries and it has advanced biological manufacturing operations across 12 facilities, including state-of-the-art recombinant production and plasma fractionation. Headquartered in Northern Illinois, Baxalta has 16,000 employees worldwide.

Forward-Looking Statements

This release includes forward-looking statements concerning ONCASPAR, including expectations with regard to commercial launch plans and potential impact on patients. Such statements are made of the date that they were first issued and are based on current expectations, beliefs and assumptions of management. Forward-looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond Baxalta's control and which could cause actual results to differ materially from those in the forward-looking statements, including the following: satisfaction of regulatory and other requirements; actions of regulatory bodies and other governmental authorities; changes in laws and regulations; product quality, manufacturing or supply issues; patient safety issues; and other risks identified in Baxalta's filings with the Securities and Exchange Commission, all of which are available on Baxalta's website. Baxalta expressly disclaims any intent or obligation to update these forward-looking statements except as required by law.

References

1. Acute lymphoblastic leukemia. Medline Plus. 2014. Available at: www.nlm.nih.gov/medlineplus/ency/article/000541.htm.
2. Vassilios, Avramis and Prakash, Nidhi Tiwari. Asparaginase (native ASNase or pegylated ASNase) in the treatment of acute lymphoblastic leukemia). Int J Nanomedicine. 2006 Sep; 1(3): 241–254.
3. Oncaspar Summary of Product Characteristics for the European Union.

Baxalta and ONCASPAR are trademarks of Baxalta Incorporated.