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news.Abraxis BioScience has agreed a Phase III trial design with the FDA under a special prototcol agreement for Abraxane as an injectable suspension for the treatment of non-small cell lung cancer in the first-line setting.
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The agreement has determined that the design and planned analysis of the study addresses the objectives necessary to support a regulatory submission.
The trial comparing weekly 100mg/m2 Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin bound),days 1, 8 and 15 of each cycle, and 200mg/m2 of Bristol-Myers Squibb’s Taxol (paclitaxel) injection every three weeks.
Carboplatin will be administered at AUC=6 on day 1 of each cycle repeated every three weeks in both treatment arms. The study will enroll approximately 1,000 patients with stage IIIb and IV non-small cell lung cancer. The primary endpoint of the study is overall response rate and enrollment of this trial will begin immediately.
Patrick Soon-Shiong, chairman and CEO, said: “We are very excited about the initiation of this clinical trial and the potential of Abraxane to treat people diagnosed with non-small cell lung cancer. The special protocol assessment agreement is an important step in the continued development of Abraxane and provides a clear pathway for an additional approved indication if the study endpoints are achieved.”