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FDA Approves ABRAXANE® For The First-Line Treatment Of Advanced Non-Small Cell Lung Cancer

Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) has approved ABRAXANE ® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) 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.

“Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Dr. Mark A. Socinski, MD, Director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of ABRAXANE phase II and phase III lung cancer trials. “The FDA approval of ABRAXANE is exciting for healthcare professionals because it offers an important new treatment option for all types of non-small cell lung cancer patients, in an area that has seen few treatment advancements in recent years.”

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 non-small cell lung cancer (NSCLC) received either ABRAXANE (100mg/m 2) weekly plus carboplatin (AUC=6) every three weeks (n=521) or paclitaxel (200mg/m 2) 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%).

The most common adverse reactions (≥20%) of ABRAXANE in combination with carboplatin for NSCLC are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.

Additional regulatory submissions have been filed in Japan, Australia and New Zealand with anticipated decisions in 2013.

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