Four independent studies on Voraxaze® published in the European

Vienna, June 09, 2022 (GLOBE NEWSWIRE) — The European Hematology Association (EHA) conference has published four independent studies on Voraxaze® (glucarpidase) by various researchers for inclusion in its June 2022 EHA Hybrid Congress Abstract Book and for publication in HemasphereEHA’s open access journal.

The four summaries are the result of independent studies in Europe and the United States; three explore whether to regularly give Voraxaze® in combination with high-dose methotrexate (“planned use”) may reduce toxicity, manage risk to patients and help them complete treatment.

  • INTENDED-USE GLUCARPIDASE FOR EXTERNAL ADMINISTRATION OF HIGH-DOSE METHOTREXATE (HD-MTX) IN PATIENTS WITH CNS LYMPHOMA (CNSL) DURING THE COVID-19 PANDEMIC, by Lauren Schaff, Mina Lobbous, Dean Carlow, Lisa DeAngelis, Louis Burt Nabors, and Christian Grommes, demonstrates the feasibility of planned use of Voraxaze to facilitate outpatient administration of HD-MTX to patients with CNS lymphoma . Twenty outpatient treatments of HD-MTX with glucarpidase were administered to a total of 7 patients. Some Grade 1 and Grade 2 adverse events attributable or possibly attributable to Voraxaze were noted. None of the patients required hospitalization during treatment. [Link to abstract]
  • REDUCTION OF METHOTREXATE (MTX) LEVELS AFTER GLUCARPIDASE IN PATIENTS WITH DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL) AT RISK OF CENTRAL NERVOUS SYSTEM (CNS) DAMAGE WHO RECEIVE HD-MTX: PHASE 2 by Adolfo De La Fuente, Francisco Javier Peñalver, Pilar Herrera, Raul Cordoba, Carmen Martinez Chamorro, Maria Teresa Olave, Isidro Jarque and Mónica Estévez, is a multicenter, open-label, interventional, non-randomized, phase 2 pilot study in patients with lymphoma large B-cells at high risk of CNS relapse to assess the prophylactic effect of glucarpidase in MTX-related toxicity administered after 12 hours of HD-MTX. The study aims to describe the reduction in MTX levels after routine administration of glucarpidase 12 hours after the start of HDMTX infusion in DLBCL patients at high risk of CNS involvement. This trial is not over. [Link to abstract]
  • INTENDED USE OF GLUCARPIDASE IN PATIENTS WITH CENTRAL NERVOUS SYSTEM LYMPHOMA AND KIDNEY FUNCTION DISORDERS – THE STUDY VALIDATED by Sven Liebig, Susen Burock, Immanuel Merz, Franz Knörnschild, Peggy Kießling, Kai Kappert, Ulrich Keller and Stefan Schwartz evaluates the safety as well as pharmacological efficacy of planned and repeated use of glucarpidase after HD-MTX in patients with CNSL and impaired renal function. Glucarpidase administration resulted in a rapid and pronounced reduction in blood MTX levels (>97%) within 15 minutes and within 12 treatment cycles for four patients, demonstrating that treatment with HD-MTX and glucarpidase is feasible in patients with CNSL and renal failure. [Link to abstract]
  • A POPULATION PHARMACOKINETIC MODEL OF HIGH-DOSE METHOTREXATE IN ADULTS WITH CANCER IDENTIFIES BASAL ALBUMIN, BODY WEIGHT, AND TIME-DEPENDENT CREATININE AS PREDICTORS OF ACUTE KIDNEY INJURY by Scott Howard, Manuel Ibarra, Ryan Combs, and Paula Schaiquevich, describes a population pharmacometric model of HD-MTX clearance developed by the authors that takes into account weight, albumin, and time-dependent creatinine to predict the ARI and guide supportive care in patients with delayed disease. Elimination of HD-MTX. AKI patients who did not receive glucarpidase experienced a significantly longer hospital stay (p

“We are excited to see top researchers working to explore how regular administration of Voraxaze® in combination with methotrexate could improve cancer care for appropriate patients,” said Christon Hill, Group Chief Innovation Officer for SERB and BTG Specialty Pharmaceuticals. “These encouraging early results suggest that such treatment regimens can help manage patient risk and ensure that more patients are able to complete their cancer treatment.”

About Voraxaze® (glucarpidase)

Voraxaz® (glucarpidase) is currently approved in all member states of the European Union as well as in Iceland, Liechtenstein and Norway, where it is designated as an orphan drug.

Voraxaz® is approved by the European Commission to reduce the toxic plasma concentration of methotrexate in adults and children (aged 28 days and older) with delayed methotrexate elimination or at risk of methotrexate toxicity.

Detailed recommendations for the use of Voraxaze ® are described in the Summary of Product Characteristics (SmPC) and in the US Prescribing Information (USPI).

SERB Specialty Pharmaceuticals market Voraxaze® in the European Union. BTG Voraxaze Specialty Pharmaceuticals Market® in the USA. SERB acquired BTG Specialty Pharmaceuticals in March 2021. Glucarpidase is sold in Japan as Megludase® by BTG’s marketing partner, Ohara Pharmaceutical Co.

About SERB and BTG Specialty Pharmaceuticals

Together, SERB and BTG Specialty Pharmaceuticals form a growing specialty pharmaceutical company and a dedicated ally of healthcare providers treating critically ill patients, with a focus on emergency care and rare diseases. For more than 30 years, we have made it possible to treat these complex and life-threatening conditions, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. As a fully integrated company, we have the experience and capabilities to source, develop and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain.

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