EU approves Abraxane for NSCLC-Celgene

The European Commission has approved Abraxane (paclitaxel formulated as albumin-bound nanoparticles, or nab-paclitaxel), from Celgene, in combination with carboplatin for the first-line treatment of Non-Small Cell Lung Cancer in adult patients who are not candidates for potentially curative surgery and/or radiation therapy. The EC decision follows the positive CHMP opinion received on 23 January and is based on the results of a multicenter, randomized, open-label study including 1,052 chemotherapy-naive patients with Stage IIIb/IV non-small cell lung cancer. The study compared Abraxane in combination with carboplatin versus solvent-based paclitaxel in combination with carboplatin as first-line treatment in patients with advanced non-small cell lung cancer.

The primary efficacy endpoint, overall response rate, was significantly higher for patients in the Abraxane/carboplatin arm at 33%, compared with patients in the control arm, at 25%. The most common adverse reactions (? 20%) of Abraxane in combination with carboplatin for NSCLC were anaemia, neutropenia, thrombocytopenia, peripheral neuropathy, nausea, and fatigue.