APP and American BioScience file NDA for Abraxane
US companies American Pharmaceutical Partners (APP) and American BioScience (ABI) have completed the filing of a fast-track New Drug Application (NDA) to the US FDA for Abraxane for the treatment of metastatic breast cancer.
US companies American Pharmaceutical Partners (APP) and American BioScience (ABI) have completed the filing of a fast-track New Drug Application (NDA) to the US FDA for Abraxane for the treatment of metastatic breast cancer.
As part of the NDA filing, ABI has requested FDA to consider the application for priority review designation, which could potentially accelerate the approval of Abraxane.
Using proprietary nanoparticle technology, Abraxane combines the active drug paclitaxel with a natural protein called albumin into a nanoparticle 1/100th the size of a red blood cell, avoiding the need for any solvent. Abraxane is the first solvent-free nanoparticle albumin-bound chemotherapeutic, and may potentially exploit an inherent pathway for albumin receptor-mediated transport of drugs across endothelial cell walls of tumour neovasculature.
The filing of the NDA is based upon supportive Phase I and II clinical trials of Abraxane and a pivotal randomised controlled Phase III trial that compared the safety and efficacy of 260mg/m2 of Abraxane to 175mg/m2 of Taxol administered every three weeks in 460 patients with metastatic breast cancer. The Phase III trial demonstrated that Abraxane resulted in an almost doubling of the response rate and a prolongation of time to tumour progression in first and second line patients with metastatic breast cancer.
'Targeting endothelial cell transport is a novel approach to increasing drug concentration in the tumour and provides the opportunity to exploit a natural biological pathway the malignant cell inherently uses to supply itself nutrients and energy for rapid growth,' said Dr Patrick Soon-Shiong, chairman, president and ceo of APP. 'Using this mechanism, the target would be shifted from the tumour cells themselves to the specific albumin receptor on the blood vessel wall of the tumour neovasculature.
'Abraxane represents the first example of the albumin-bound nanoparticle technology platform that may have the potential to exploit this natural biological pathway.'