(Alliance News) - GlaxoSmithKline PLC on Wednesday said that the European Commission has granted conditional marketing authorisation for Blenrep, or belantamab mafodotin, as monotherapy for the treatment of multiple myeloma, a type of blood cancer.
Multiple myeloma is a cancer that forms in a type of white blood cell called a plasma cell.
Blenrep was approved for adults who have received at least four prior therapies and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and an anti-CD38 monoclonal antibody, and who have demonstrated disease progression on the last therapy.
The Brentford, England-based company said that the approval is based on data from the Driving Excellence in Approaches to Multiple Myeloma study including a 13-month follow-up data.
The study data demonstrated that treatment with single-agent Blenrep resulted in an overall response rate of 32%. The median duration of response was 11 months and median overall survival was 13.7 months.
Earlier in August, the US Food & Drug Administration approved Blenrep as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies.
Shares in Glaxo on Wednesday closed 0.5% lower at 1,510.80 pence each in London on Wednesday.
By Tapan Panchal; tapanpanchal@alliancenews.com
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Glaxosmithkline (GSK)