British drugmaker GSK announced the withdrawal of its blood cancer drug Blenrep (belantamab mafodotin-blmf) from the US market following the request of the US Food and Drug Administration (FDA).
GSK says the agency’s request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the FDA Accelerated Approval regulations.
“We respect the Agency’s approach to the accelerated approval regulations and associated process. Multiple myeloma is a challenging disease, with poor outcomes for patients whose disease has become resistant to standard-of-care treatments. We will continue the DREAMM clinical trial program and work with the US FDA on a path forward for this important treatment option for patients with multiple myeloma,” Sabine Luik, GSK’s Chief Medical Officer, said in a press release.
In 2020, the FDA granted accelerated approval for Blenrep, a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies. The confirmatory trial was necessary to prove the drug’s safety and efficacy.
Findings of the DREAMM-3 phase III trial, released last month, suggest that Blenrep did not significantly prolong the median progression-free survival (PFS) and overall survival compared to PomDex (pomalidomide plus dexamethasone), a standard treatment for myeloma.
Myeloma is a cancer of the plasma cells — white blood cells that make antibodies protecting from infections.
Age is a risk factor for the disease, as people younger than 45 years rarely develop myeloma. Men are more likely to suffer from the disease than women, and myeloma is more than twice as common among Black people as among White people, according to the Centers for Disease Control and Prevention (CDC).
Being overweight and having obesity is also associated with a higher risk of getting multiple myeloma.