Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.GlaxoSmithKline (GSK) has secured approval from the US Food and Drug Administration (FDA) for its BLENREP (belantamab mafodotin-blmf) to treat patients with relapsed or refractory multiple myeloma.
GSK's corporate headquarters in Brentford, London. (Credit: GlaxoSmithKline plc / SmugMug+Flickr)
Subscribe to our email newsletter
BLENREP has been approved as a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma who have secured at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor and an immunomodulatory agent.
BLENREP is an antibody-drug conjugate that includes a humanised anti-B cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F through a non-cleavable linker.
GSK’s BLENREP, which is permitted under accelerated approval, is claimed to be the first anti-BCMA therapy approved across the world.
The normal function of BCMA is to boost plasma cell survival by transduction of signals from two ligands such as BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand).
In the DREAMM-2 study, the treatment with single-agent BLENREP 2.5 mg/kg every three weeks showed a clinically meaningful overall response rate (ORR) of 31% in patients who had secured a median of seven prior lines of treatment, said the company.
In 2017, the company secured a breakthrough therapy designation from the FDA for BLENREP.
GSK licenced the drug linker technology from Seattle Genetics, while monoclonal antibody is generated using POTELLIGENT technology licenced from BioWa.
GSK chief scientific officer and president Dr Hal Barron said: “As the second most common form of blood cancer in the US, multiple myeloma is an incurable and devastating disease.
“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.’’
In April this year, GSK joined forces with French pharma company Sanofi for the development of an adjuvanted vaccine for Covid-19 disease.
