Green light for the Jazz Pharmaceuticals drug in Europe. The biopharmaceutical company has received authorization from the European Commission to begin marketing Enrylaze, a basic component for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients. The European Commission’s approval extends to all EU member states, as well as Iceland, Norway and Liechtenstein.
The approval is based on the results of a phase 3 clinical trial, conducted in collaboration with the Children’s Oncology Group (COG) in a cohort of 228 pediatric and adult patients with ALL and LBL. The firm has confirmed that “the safety profile of the drug was consistent with the reported safety information for patients with ALL and LBL receiving asparaginase with combination chemotherapy.”
Robert Iannone, global head of research and development at Jazz Pharmaceuticals, said: “Healthcare professionals in the European Union will now have access to a new recombinant asparaginase derived from Erwinia with multiple dosing and administration options to address the individual needs of their patients, which will allow them to complete their treatment scheme according to the prescription ”, according to the manager.
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The EC’s approval of Jazz Pharmaceuticals’ leukemia drug extends to all EU member states, as well as Iceland, Norway, and Liechtenstein
Enrylaze is an asparaginase derived from Erwinia that was approved by the United States Food and Drug Administration (FDA) in June 2021 and began being marketed in July of that same year in the United States and Canada.
Acute lymphoblastic leukemia is a cancer of the blood and bone marrow that represents 80% of leukemia diagnoses in children, with a total incidence in Europe of 1.28 per 100,000 inhabitants. For its part, lymphoblastic lymphoma is a rare, rapidly growing, and aggressive subtype of non-Hodgkin lymphoma that is most frequently seen in adults under 35 years of age.
Jazz Pharmaceuticals is a biopharmaceutical company dedicated to the development of drugs in neuroscience and oncology. Founded in 2003 in Ireland, two years later it acquired Orphan Medical and its product, Xyrem. The Irish company has an agreement with Pharma Mar for the marketing of the drug Zepzelca on US soil. In fact, the Spanish company received 89 million euros for the approval of Zepzelca in the United States.
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