Celgene announced that the FDA has approved Abraxane (nanoparticle albumin bound [nab]-paclitaxel for injectable suspension) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
The approval of supplemental New Drug Application (sNDA) is based on the results of a CA-031, a Phase 3, multi-center randomized open-label study where patients with NSCLC received either Abraxane (100mg/m2) weekly plus carboplatin (AUC=6) every three weeks or paclitaxel (200mg/m2) every three weeks plus carboplatin (AUC=6). The study met its primary endpoint demonstrating a statistically significantly higher overall response rate in the Abraxane arm compared to those in the paclitaxel arm (33% vs. 25%).
Abraxane, a taxane antimicrotubule agent, was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy.
For more information call (908) 679-9000 or visit www.abraxane.com.