logo
Share SHARE
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
U.S. food maker Kraft Heinz Co., which had offered $143 billion in cash and stock to buy Anglo-Dutch consumer goods company Unilever, Sunday said it has amicably agreed to withdraw its proposal for a combination of the two companies. Dairy giant Saputo Inc. is voluntarily recalling certain Gouda cheese products in the U.S. due to potential listeria contamination. Saputo said one of its suppliers, Deutsch Kase Haus, LLC of Middlebury, Indiana, notified the company that some specialty Gouda cheese products that it supplied to Saputo's Green Bay, Wisconsin facility may have been contaminated with Listeria monocytogenes. Amazon is exploring the possibility of using parachutes to drop drone-delivered packages. The e-commerce giant has been granted a patent titled, "Maneuvering a package following in-flight release from an unmanned aerial vehicle".
comments powered by Disqus
Follow RTT