(Alliance News) - FTSE 100-listed GlaxoSmithKline PLC on Thursday said the US Food & Drug Administration has approved Blenrep as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma.
Blenprep will be used for adult patients, who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent, the drugmaker said.
"Blenrep is the first approved anti-BCMA therapy and has the potential to transform the treatment of patients with relapsed or refractory myeloma who have limited treatment options today," said Hal Barron, chief scientific officer & president of Research & Development at GSK.
The Brentford, England-based company said that the approval follows the Dreamm-2 study, where treatment with single-agent Blenrep every three weeks demonstrated a clinically meaningful overall response rate of 31% in patients who had received a median of seven prior lines of treatment.
The median duration of response had not been reached at the six-month analysis, Glaxo said, but 73% of responders had a duration of response equal to or greater than six months.
Paul Giusti, president & chief executive of the Multiple Myeloma Research Foundation, said: "The approval of Blenrep is an important advancement for patients with relapsed or refractory multiple myeloma, as it brings a much-needed new treatment to patients who face limited options due to their progressing disease."
By Evelina Grecenko; evelinagrecenko@alliancenews.com
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Glaxosmithkline (GSK)