UK pharma major GlaxoSmithKline (LSE: GSK) today announced that the European Commission has granted conditional marketing authorization for Blenrep (belantamab mafodotin), meaning that the drug is the first B-cell maturation antigen (anti-BCMA) to be cleared for marketing on both sides of the Atlantic.
Blenrep is approved as monotherapy for the treatment of multiple myeloma (MM) in adult patients 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 conditional approval means that GSK is required to present additional data to keep the authorization.
Dr Hal Barron, chief scientific officer and president R&D, GSK, said: “The approval of Blenrep marks an important step forward for patients in Europe where nearly 50,000 new cases of multiple myeloma are diagnosed each year. Unfortunately, most of these patients will relapse or stop responding to current therapies so I am pleased that today’s news will give patients with limited treatment options access to the first approved anti-BCMA therapy.”
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