Abraxis (ABII)

[surf1944]

8:05AM Abraxis BioScience announces that ABRAXANE meets primary endpoint in Phase 3 trial for advanced non-small cell lung cancer (ABII) 39.85 : Co announces that its randomized registrational Phase 3 clinical trial comparing ABRAXANE (protein-bound paclitaxel) with Taxol (paclitaxel) injection, both in combination with carboplatin, met the study's primary endpoint by demonstrating that ABRAXANE showed a significant improvement in overall response rate as compared to Taxol, in the first-line treatment of patients with advanced non-small cell lung cancer, as assessed by independent radiologist review. This trial is the subject of a special protocol assessment with the FDA, which means that the design, clinical endpoints and statistical analyses of the trial have been previously agreed upon by the FDA. Specifically, the FDA agreed that the demonstration of a statistically superior response rate of the ABRAXANE and carboplatin combination over the Taxol and carboplatin combination would be sufficient to submit a supplemental new drug application for approval of ABRAXANE in combination with carboplatin for first line NSCLC.