Breaking News
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

Celgene Reveals Multiple Analyses Data Of Abraxane In Non-Small Cell Lung Cancer

6/2/2012 10:54 PM ET

Celgene International Sarl, a subsidiary of Celgene Corp. (CELG: Quote), Sunday revealed data from multiple presentations evaluating Abraxane in combination with carboplatin in patients with advanced non-small cell lung cancer.

The two reports presented data from retrospective analyses of CA-031, the phase III, multi-center, randomized study where patients received either nab-paclitaxel weekly plus carboplatin every three weeks or paclitaxel every three weeks plus carboplatin as first-line therapy for advanced non-small cell lung cancer.

Based on the data from CA-031, Celgene submitted an sNDA for Abraxane for the first-line treatment of patients with advanced non-small cell lung cancer with the U.S. Food and Drug Administration in December 2011. The current PDUFA (Prescription Drug User Fee Act) date for the submission is October 12, 2012.

Results of the study published on April 30, 2012 in the Journal of Clinical Oncology demonstrated a higher overall response rate, the approved primary end-point of the study based on a Special Protocol Assessment, for patients in the nab-paclitaxel arm compared to those in the paclitaxel arm.

The first sub-analysis evaluated elderly patients in the study and patients under 70. In both groups, overall response rate was higher in patients receiving nab-paclitaxel, though the difference was not significant in elderly patients between the arms of the study.

The second report evaluated patients with squamous-cell histology and non-squamous cell patients. The nab-paclitaxel arm demonstrated a significantly higher overall response rate and a slight improvement in overall survival, compared to the paclitaxel arm.

These results are from an investigational study and Abraxane is not indicated in the treatment of non-small cell lung cancer.

CELG traded on Friday at $65.33, down $2.92 or 4.28%, on a volume of 4.5 million shares on the Nasdaq.

Register
To receive FREE breaking news email alerts for Celgene Corporation and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Chipmaker Advanced Micro Devices Inc. said Thursday after the markets closed that its first quarter loss narrowed from last year, helped by strong revenue growth in its graphics and visual solutions business. The company's quarterly earnings per share, excluding items, also came in above analysts' expectations as did its quarterly revenue. After trending higher over the past few sessions, stocks showed a lack of direction throughout the trading day on Thursday. The major averages spent the session bouncing back and forth across the unchanged line before ending the day mixed. While the major averages closed on opposite sides of the unchanged line, they all showed only modest moves. U.S. Secretary Of State John Kerry said Thursday that he and his counterparts from Russia, Ukraine and the European Union have reached an agreement on a preliminary plan for ending the ongoing crisis in Ukraine. Kerry was speaking at the end of the Ukraine contact group's first meeting, comprising the foreign ministers of Russia, Ukraine, the EU and the U.S., in the Swiss city of Geneva.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.