FONT-SIZE Plus   Neg

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

Celgene Corp.'s (CELG) 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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Flying is the passion for British aviatrix Tracey Curtis Taylor, and she is now on a solo flight to cross three continents and 23 countries in her own vintage open cockpit biplane. She has already crossed half of her journey from U.K. to Australia with a target to cover 13 thousand miles. Sony Computer Entertainment Inc. Wednesday revealed that its popular PlayStation4 computer entertainment system has achieved total sales of more than 30.2 million units worldwide in a period of two years. The PS4 system is currently available in 124 countries. Cement giant LafargeHolcim (HCMLY.PK, HCMLF.PK), formed by the combination of French Lafarge and Swiss peer Holcim, Wednesday said its sales declined for the third quarter as well as nine months.
comments powered by Disqus
Trade CELG now with 
Follow RTT