Celgene Corporation (CELG) Friday announced that the U.S. Food and Drug Administration, or the FDA has approved ABRAXANE for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
The integrated global biopharmaceutical company stated that ABRAXANE sNDA approval is based upon the results of CA-031, a phase III, multi-center, randomized open-label study where patients with advanced non-small cell lung cancer received either ABRAXANE weekly plus carboplatin every three weeks or paclitaxel every three weeks plus carboplatin.
The company further added that the study met its primary end-point demonstrating a statistically significantly higher overall response rate for patients in the ABRAXANE arm compared to those in the paclitaxel arm.
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