Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

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

RELATED NEWS
Trade CELG now with 

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

Quick Facts

Editors Pick
Less than a month after resigning from Congress, former House Majority Leader Eric Cantor, R-Virg., has made the move from Washington to Wall Street by joining boutique investment bank Moelis & Co. A statement from Moelis said Cantor will serve as Vice Chairman and Managing Director and also be elected to the company's Board of Directors. Stocks continue to show a lack of direction in mid-day trading on Tuesday following the long, holiday weekend. Even with the lackluster performance, the markets are largely holding on to the bulk of their recent gains. After reporting an unexpected drop in U.S. construction spending in the previous month, the Commerce Department released a report on Tuesday showing that construction spending rebounded by more than expected in the month of July.
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.