From Healio.com with addition thoughts from Edward A. Faber Jr., D.O., a medical oncologist and transplant specialist with OHC. May 8, 2018
May 10, 2018
Edward A. Faber Jr., DO
Medical Oncologist and Transplant Specialist with OHC
Patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant now have access to a new treatment that was recently expanded for use by FDA.
The FDA expanded the approval of daratumumab for use in combination with bortezomib, melphalan and prednisone (known as VMP), according to the agent’s manufacturer.
The FDA based this expanded approval on data from the phase 3 ALCYONE study — published in The New England Journal of Medicine — of 706 patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplantation. Researchers randomly assigned patients to receive VMP or daratumumab plus VMP.
Daratumumab plus VMP reduced the risk for disease progression or death by 50% compared with VMP alone.
“This is exciting because the approval represents the first addition of a monoclonal antibody based therapy, in the upfront setting” said Edward A. Faber Jr., D.O., M.S., a medical oncologist and transplant specialist with OHC who specializes in the care of patients with multiple myeloma. “Multiple myeloma remains incurable, but the addition of a well tolerated monoclonal antibody to the VMP platform was shown to reduce the risk of progression and extend remission – a very important message, especially to patients whose pre-existing health issues may limit a more intense initial strategy.”
“Slowing the progression of myeloma translates to more time in remission for those battling the disease. This latest approval for Darzalex in combination with VMP is an exciting step forward for newly diagnosed patients and the health care teams who treat them,” Paul Giusti, president and CEO of the Multiple Myeloma Research Foundation, said in the release.
Source: Healio.com
