(Reuters) – Independent safety monitors determined that Celgene Corp’s experimental cancer drug met the main goal of a late stage trial of improving progression-free survival in multiple myeloma patients who have relapsed or not responded to prior treatment.
The monitors also determined that the drug pomalidomide given in combination with a low dose of existing treatment dexamethasone was superior to a high dose of the existing treatment in improving overall survival, the cancer drugmaker said.
Following the interim analysis, the study’s data safety monitoring board recommended that patients who had not yet progressed in the trial’s high-dose dexamethasone control arm should be started on Celgene’s combination.
Multiple Myeloma is a cancer of plasma cells – a type of white blood cell responsible for producing antibodies – that affects the bone marrow.
The National Cancer Institute estimates that 21,700 men and women in the United States will be diagnosed with myeloma in 2012.
In July, Celgene’s CEO Robert Hugin had said that he expects pomalidomide to generate sales of more than $1 billion treating multiple myeloma in a market that is expected to reach $5.4 billion by 2016 according to analysts.
U.S. health regulators are set to decide on marketing approval for the drug on February 10, 2013, while European regulators are expected to rule on the drug in the second half of 2013.
(Reporting by Vidya P L Nathan; Editing by Anthony Kurian)
Article source: http://www.reuters.com/article/2012/10/23/us-celgene-study-multiplemyeloma-idUSBRE89M0S320121023