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BTG : NCCN issues first pediatric acute lymphoblastic leukemia guidelines, including use of Voraxaze

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07/12/2019 | 04:19 pm

BTG plc (LSE: BTG), the global healthcare company, today highlighted the first publication of National Comprehensive Cancer Network (NCCN) pediatric acute lymphoblastic leukemia (ALL) guidelines including consideration of Voraxaze (glucarpidase).

This is in addition to updated NCCN guidelines for central nervous system (CNS) cancer, which now reference new consensus guidelines for Voraxaze. Inclusion of Voraxaze is based on publication of consensus guidelines for use of Voraxaze in patients with high-dose methotrexate-induced acute kidney injury and delayed methotrexate clearance in The Oncologisti.

High-dose methotrexate, defined as a dose higher than 500 mg/m2, is used to treat a range of adult and childhood cancers, including, osteosarcoma, acute lymphoblastic leukemia, and primary central nervous system lymphoma. Acute kidney injury due to high-dose methotrexate is a serious, life-threatening toxicity that can occur in pediatric and adult patients. Voraxaze is indicated for the treatment of toxic plasma methotrexate concentrations (>1 mol/L) in patients with delayed methotrexate clearance due to impaired renal function.

'NCCN is continuing to ensure the medical community has access to current best practice on how to manage delayed methotrexate elimination due to acute kidney injury,' said Suzanne Ward, PharmD, MBA, Senior Director of Medical Strategy for Specialty Pharmaceuticals at BTG. 'The published guidelines referred to by NCCN provide very specific plasma methotrexate concentration thresholds as early as 24 hours following the start of methotrexate infusion. This allows clinicians to efficiently identify at-risk patients so treatment occurs quickly, minimizing unnecessary over-exposure to methotrexate and toxicity progression.'

About Methotrexate Toxicity

Methotrexate is a potent anticancer agent used in high doses (>500 mg/m2) to treat osteosarcoma, non-Hodgkin lymphoma, CNS lymphoma, and adult and pediatric acute lymphoblastic leukemia. Because methotrexate is primarily cleared by the kidneys, high doses can induce kidney dysfunction and delayed methotrexate elimination. Exposure to elevated concentrations of methotrexate for minutes to hours may lead to acute renal toxicity and other serious systemic adverse reactions. Early treatment with Voraxaze is associated with significantly lower rates of toxicity and mortality.ii

About Voraxaze

Acute kidney injury due to high dose methotrexate (HDMTX) is a serious, life threatening toxicity that can occur in pediatric and adult patients. Voraxaze (glucarpidase) is a treatment approved by the Food and Drug Administration for the treatment of toxic plasma methotrexate concentrations (>1 mol/L) in patients with delayed methotrexate clearance due to impaired renal function. In clinical studies, all patients treated with Voraxaze experience rapid reductions in plasma MTX concentrations and 91% of patients achieved sustained reductions for up to 8 days.ii

About BTG Pharmaceuticals

BTG Pharmaceuticals provides antidotes that counteract the potentially life-threatening effects associated with exposure or overexposure to certain toxins. These acute care products are typically used in emergency rooms and intensive care units to treat patients for whom there are limited or no existing treatment options. We are dedicated to delivering quality medicines that make a real difference to patients through the development, manufacture, and commercialization of pharmaceutical products.

Contact:

Chris Sampson

Tel: +44 (0)20 7575 1595

Indication and Limitations of Use

Voraxaze (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 mol/L) in patients with delayed methotrexate clearance due to impaired renal function

Voraxaze is not indicated for use in patients who exhibit the expected clearance of methotrexate (plasma methotrexate concentrations within 2 standard deviations of the mean methotrexate excretion curve specific for the dose of methotrexate administered) or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate

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