Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

Celgene: MM-003 Meets Primary Endpoint Of Improvement In PFS - Quick Facts

12/11/2012 8:59 AM ET

Celgene Corp.'s (CELG: Quote) unit, Celgene International Sàrl, reported phase III study data MM-003 of pomalidomide plus low-dose dexamethasone compared with high-dose dexamethasone in patients with refractory multiple myeloma who have failed therapy with both bortezomib and lenalidomide, administered either alone or in combination. MM-003 met the primary endpoint of improvement in progression-free survival or PFS.

PFS was significantly longer in patients who received pomalidomide plus low-dose dexamethasone compared with those who received high-dose dexamethasone.

According to the study design, an interim analysis of overall survival was conducted. During this analysis, pomalidomide plus low-dose dexamethasone demonstrated a highly statistically significant improvement in overall survival that crossed the upper boundary for superiority. Consequently, the Data Monitoring Committee urged that patients who had not yet progressed in the high-dose dexamethasone arm should be crossed over to pomalidomide plus low-dose dexamethasone.

A Marketing Authorisation Application for pomalidomide combined with low-dose dexamethasone was submitted to the EMA in May 2012, and Celgene expects a decision by European regulatory authorities in the second half of 2013. Further, a new drug application has been accepted for review by the U.S. Food and Drug Administration, with a Prescription Drug User Fee Act date of Feb. 10, 2013.

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.