FDA approves Abraxane (Celgene Oncology) for NSCLC

The FDA has on 11 October 2012 approved Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) from Celgene Oncology, 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 Abraxane sNDA approval is based upon the results of CA-031, a phase III, multi-center, randomized open-label study where patients with advanced NSCLC received either Abraxane (100mg/m2) weekly plus carboplatin (AUC=6) every three weeks (n=521) or paclitaxel (200mg/m2) every three weeks plus carboplatin (AUC=6) (n=531). 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 (33% vs 25%).

In the phase III study, Abraxane demonstrated a higher overall response rate as compared to paclitaxel for squamous cell carcinoma (41% vs. 24%) and large cell carcinoma (33% vs. 15%). Abraxane achieved a similar overall response rate to paclitaxel in patients with carcinoma/adenocarcinoma (26% vs. 27%).

Abraxane is already approved in the USA and EU for metastatic Breast Cancer.