LOS ANGELES--(BUSINESS WIRE)--Abraxis BioScience, Inc. (NASDAQ:ABBI), an integrated, global biopharmaceutical company, today announced that it has reached a definitive agreement with the U.S. Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process on the Phase III trial design of the company’s pivotal study with ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin bound) for the treatment of non-small cell lung cancer in the first-line setting. In the agreement, the FDA has determined that the design and planned analysis of the study addresses the objectives necessary to support a regulatory submission.
