"This approval means that women with metastatic breast cancer no longer need to endure the toxicities associated with solvents and will no longer need steroid premedication when they receive this albumin-bound form of paclitaxel. Our Phase III study in both first and second line metastatic breast cancer patients showed that ABRAXANE could be administered at 50% higher dose, resulting in almost doubling the response rates and longer time to tumor progression when compared with Taxol," said principal clinical trial investigator William J. Gradishar, M.D., Associate Professor of Medicine, Division of Hematology and Medical Oncology and Co-Director, Lynn Sage Breast Cancer Program at Northwestern Memorial Hospital. "In addition, in our research women who no longer responded to some of the more common treatments showed improvement with ABRAXANE and experienced less severe side effects that made treatment more tolerable."
ABRAXANE is engineered using a proprietary process (protein bound nanoparticle technology) to create tiny particles (nanoparticles 100th the size of a red blood cell) in which the active chemotherapeutic drug, paclitaxel, is bound to a naturally occurring protein called albumin. By using this nanotechnology, the active component (paclitaxel) can be delivered into the body at a 50% higher dose over 30 minutes. This contrasts with Taxol in which paclitaxel is dissolved in the toxic solvent Cremophor-EL®, requiring premedication with steroids and anti-histamines to avoid hypersensitivity reactions and must be given using infusions of up to three hours.
The approval of ABRAXANE was based on data from three clinical trials of patients with metastatic breast cancer, including two Phase II open label studies of 106 patients on ABRAXANE and a Phase III randomized study involving 454 patients randomized 1:1 into two arms of ABRAXANE or a Cremophor-based paclitaxel injection (Taxol). Because ABRAXANE is solvent-free, solvent-related toxicities are eliminated and premedication is not required. The response rate was almost twice that for all patients treated with ABRAXANE when compared those receiving the Cremophor-based paclitaxel injection. Without the toxic solvents, ABRAXANE could be given at higher doses than Taxol, which may account, in part, for the increased anti-tumor activity. In addition, albumin is a protein that normally transports nutrients to cells and has been shown to accumulate in rapidly growing tumors. Therefore, ABRAXANE's increased effectiveness may also be due to preferential delivery of albumin-bound paclitaxel to cancer cells.
ABRAXANE was developed by American Bioscience and will be marketed by Abraxis Oncology, a division of American Pharmaceutical Partners (NASDAQ:APPX).