Approvals In Brief
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
GSK Arranon to launch in early 2006: GlaxoSmithKline's leukemia and lymphoma therapy Arranon (nelarabine) will debut early next year following accelerated approval Oct. 28. The orphan drug is indicated for "treatment of patients with T-cell acute lymphoblastic leukemia (T-ALL) and T-cell lymphoblastic lymphoma (T-LBL) whose disease has not responded to or has relapsed following treatment with at least two chemotherapy regimens." Approval of the "last resort" chemotherapy was based on two open-label, single-arm Phase II trials that showed complete disappearance of cancer cells in nine (23%) of the 39 pediatric patients treated and six (21%) of the 28 adults studied, FDA says. Complete disappearance of cancer cells lasted from 3.3 to 9.3 weeks in pediatric patients and from 4 to 195 weeks in adults. GSK will conduct a Phase III confirmatory study to fulfill its accelerated approval requirement...
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Approval In Brief
Halozyme's Hylenex is NME: Recombinant human hyaluronidase (formerly Enhanze SC) spreading agent is approved Dec. 2 as a new molecular entity via the 505(b)(2) pathway, entering an increasingly crowded hyaluronidase market. FDA is considering all hyaluronidase products to be NMEs because of the lack of characterization. Hylenex, which will be marketed by Baxter, is indicated "as an adjuvant to increase the absorption and dispersion of other injected drugs, for hypodermoclysis and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents." PrimaPharm's bovine-derived hyaluronidase Hydase was approved Oct. 25, while Amphastar's bovine-derived Amphadase and Ista's ovine-derived Vitrase were both approved in 2004. All four of the approved agents received priority reviews (Pharmaceutical Approvals Monthly November 2005, p. 14)...
Approval In Brief
Halozyme's Hylenex is NME: Recombinant human hyaluronidase (formerly Enhanze SC) spreading agent is approved Dec. 2 as a new molecular entity via the 505(b)(2) pathway, entering an increasingly crowded hyaluronidase market. FDA is considering all hyaluronidase products to be NMEs because of the lack of characterization. Hylenex, which will be marketed by Baxter, is indicated "as an adjuvant to increase the absorption and dispersion of other injected drugs, for hypodermoclysis and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents." PrimaPharm's bovine-derived hyaluronidase Hydase was approved Oct. 25, while Amphastar's bovine-derived Amphadase and Ista's ovine-derived Vitrase were both approved in 2004. All four of the approved agents received priority reviews (Pharmaceutical Approvals Monthly November 2005, p. 14)...
Baxter/Halozyme Hyaluronidase Enhanze SC Set For Approval By September
Halozyme human-derived hyaluronidase Enhanze SC user fee goal is September 23 following March 23 NDA submission for use as spreading agent. Firm is highlighting greater purity than animal-derived hyaluronidase products. Baxter to market product, provide fill/finish services