The US Food and Drug Administration (FDA) has approved GlaxoSmithKline’s anti-BCMA therapy Blenrep (belantamab mafodotin-blmf) for the treatment of patients with relapsed or refractory multiple myeloma.

The drug has been indicated for use as a monotherapy treatment for adult patients who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent. It is the first anti-BCMA therapy approved anywhere in the world.

“As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease," said Hal Barron, Chief Scientific Officer and President R&D at GSK.

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," he added.

Blenrep is designed to target BCMA, a cell-surface protein that plays a crucial role in the survival of plasma cells and is expressed on multiple myeloma cells.

The approval is based on primary results from GSK’s pivotal DREAMM-2 study of Blenrep – treatment with a single-agent Blenrep dose of 2.5mg/kg 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 (DoR) had not yet been reached at the six-month analysis, although 73% of responders had a DoR equal to or greater than six months.

“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," said Paul Giusti, President and CEO of the Multiple Myeloma Research Foundation (MMRF).

"We are grateful for GSK’s continued commitment to myeloma patients and their families,” he added.