Geneva, Switzerland - New research data was presented at the 9th annual congress of the European Hematology Association confirming that treatment with VELCADETM
in patients with relapsed and refractory multiple myeloma demonstrated a survival benefit of up to one and a half years. Study findings also demonstrate that extended therapy or re-treatment with VELCADETM
beyond eight cycles is a safe option for patients. These data also re-affirm recent findings from the phase III APEX trial which showed a 30 percent reduction in the risk of death during the first year in patients with relapsed multiple myeloma receiving treatment with VELCADETM
compared to those treated with high-dose dexamethasone.
The novel cancer agent, commercialized in Europe by Ortho Biotech, the biopharmaceutical division of Janssen-Cilag, was recently approved by the European Commission (26 April) to treat multiple myeloma patients who have received at least two prior therapies and demonstrated disease progression on their last therapy.
"These data show that not only can bortezomib induce important responses in this relapsed and refractory patient population, but it can also significantly extend survival", said Dr Paul Richardson, Clinical Director of the Jerome Lipper Myeloma Center at the Dana-Farber Institute, Boston, USA and lead Investigator of the study. "The benefit offered by bortezomib is especially encouraging in this patient population in whom resistance to treatment and shortened survival constitutes a major challenge."
Investigators designed an extension of the phase II SUMMIT trial (which included a total of 202 patients) allowing a subset of patients who had achieved a response to VELCADETM in the original trial (N=46) to continue treatment or receive retreatment with the drug. In addition they followed the progress of the 156 patients from the SUMMIT trial who were not receiving extended therapy.
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