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Title: Nanoparticle Albumin-Bound Paclitaxel Approved in Australia for Metastatic Breast Cancer
URL: http://www.pslgroup.com/dg/22EEB6.htm
Doctor's Guide
October 16, 2008


NEW YORK -- October 16, 2008 -- The Therapeutic Goods Administration (TGA) in Australia has approved nanoparticle albumin-bound paclitaxel (Abraxane) 100-mg powder for injection for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.

The approval was based on the results of a phase 3 clinical trial which demonstrated that nanoparticle albumin-bound paclitaxel doubled the response rate and significantly prolonged progression-free survival and overall survival compared with paclitaxel (Taxol) in the approved indication.

The most reported serious adverse events associated with nanoparticle albumin-bound paclitaxel in the study included neutropenia, anaemia, infections, sensory neuropathy, nausea, vomiting, and myalgia/arthralgia.

Other common adverse reactions included anaemia, asthenia, diarrhoea, ocular/visual disturbances, fluid retention, alopecia, hepatic dysfunction, mucositis, and renal dysfunction.

SOURCE: Abraxis

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