BTG International Inc., the specialist healthcare company, today announces the presentation of data on Voraxaze\u00ae(glucarpidase) at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1-5, 2012 in Chicago, Illinois.<\/p>\n
BTG received US regulatory approval for Voraxaze\u00ae on 17 January 2012, and the data presented formed a key part of the Biologics License Application (BLA) submission.<\/p>\n
Clinical data on the compassionate use of Voraxaze\u00ae for methotrexate toxicity were presented at the Leukemia, Myelodysplasia, and Transplantation poster session (abstract #6530) on Friday June 1, 2012 from 1 – 5pm. A poster discussion session, presented by Dr. Brigitte Widemann from the National Cancer Institute (NCI), occurred at 4.30pm on the same day.<\/p>\n
In the study, 492 patients experiencing renal toxicity and delayed elimination of methotrexate were treated with Voraxaze\u00ae (50 U\/kg intravenously) in compassionate use trials conducted in the United States and Europe from November 1993 to June 2009. The median age of the patients in the study was 18 years (range: 5 weeks to 85 years). 63% were male. 41% had NHL, 30% had osteogenic sarcoma, 23% ALL, and 7% other malignancies. The median pre-Voraxaze\u00aemethotrexate concentration was 17 \u00b5mol\/L. 76% of patients received a single dose Voraxaze\u00ae, 22% received 2 doses, and 2% received 3 doses. The first dose of Voraxaze\u00ae was given at a median of 3 days after methotrexate administration. 156 patients had methotrexate concentrations determined by high performance liquid chromatography (HPLC) assay. At the first measurement (median 15 minutes post-Voraxaze\u00ae) serum methotrexate was reduced by a median of 99% relative to the pre- Voraxaze\u00ae baseline. At the last measurement (median 40 hours post-Voraxaze\u00ae) median serum methotrexate reduction remained at 99% compared with baseline. Among 410 patients with pre-Voraxaze\u00ae renal impairment (measured as common terminology criteria for adverse events (CTCAE) Grade 2 or higher), 64% recovered to Grade 0 or 1 after a median of 12.5 days post-Voraxaze\u00ae.<\/p>\n
Voraxaze\u00ae was well-tolerated overall; adverse events included paresthesia (2.0%), flushing (1.8%) and headache (1.0%). 8% of patients died within 30 days of Voraxaze\u00aeadministration of causes unrelated to Voraxaze\u00ae, as judged by the treating physician. Voraxaze\u00aereliably reduced serum methotrexate concentrations by 99% within 15 minutes of administration in patients with impaired renal clearance of methotrexate.<\/p>\n
Dr. Brigitte Widemann, MD with the NCI, said: \u201cThese data demonstrate that in patients receiving high-dose methotrexate chemotherapy, early recognition of renal dysfunction may warrant intervention with Voraxaze\u00ae to reduce serum methotrexate concentrations. Voraxaze\u00ae is unique in addressing an unmet medical need in the area of methotrexate-treated cancers.\u201d<\/p>\n
Guenter R. Janhofer MD, PhD, BTG\u2019s Chief Medical Officer and Head of Development commented: \u201cBTG is committed to acute care therapies in oncology, as demonstrated in these data presented at ASCO. This is the first time our comprehensive data, supporting the use of Voraxaze\u00ae in adults and children, were presented in a public forum. Voraxaze\u00ae, a newly approved therapy, provides a rapid and sustained reduction in plasma methotrexate concentration, helping physicians treat this rare but potentially life-threatening toxicity among patients receiving high-dose methotrexate cancer therapy.\u201d<\/p>\n
Indication<\/strong><\/p>\n Voraxaze\u00ae (glucarpidase) is indicated for the treatment of toxic plasma methotrexate concentrations (>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function. Voraxaze\u00ae is not indicated for use in patients who exhibit the expected clearance of methotrexate or those with normal or mildly impaired renal function because of the potential risk of subtherapeutic exposure to methotrexate.<\/p>\n Safety Information<\/strong><\/p>\n Serious allergic reactions, including anaphylactic reactions, may occur. In clinical trials the most common adverse reactions (incidence \u22651%) were paresthesias, flushing, nausea and\/or vomiting, hypotension and headache.<\/p>\n Healthcare providers should note that:<\/p>\n Methotrexate concentrations within 48 hours following glucarpidase administration can only be reliably measured by a chromatographic method due to interference from metabolites [4-deoxy-4-amino-N10-methylpteroic acid (DAMPA)]. Measurement of methotrexate concentrations within 48 hours of glucarpidase administration using immunoassays can overestimate the methotrexate concentration. Voraxaze\u00ae (glucarpidase) prescribing information January 2012<\/p>\n For further information contact:<\/strong><\/p>\n BTG<\/p>\n Ashley Tapp, Communications Manager BTG International Inc., the specialist healthcare company, today announces the presentation of data on Voraxaze\u00ae(glucarpidase) at the American Society of Clinical Oncology (ASCO) Annual Meeting on June 1-5, 2012 in Chicago, Illinois. BTG received US regulatory approval for Voraxaze\u00ae on 17 January 2012, and the data presented formed a key part of the Biologics License […]<\/p>\n","protected":false},"featured_media":0,"template":"","class_list":["post-1238","news","type-news","status-publish","hentry"],"acf":[],"yoast_head":"\n
\nLeucovorin should not be administered within 2 hours before or after a glucarpidase dose because leucovorin is a substrate for glucarpidase.1
\nReference<\/p>\n
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