FDA Panel Rejects GSK’s Blenrep for Blood Cancer

In a significant setback for GlaxoSmithKline (GSK), a U.S. Food and Drug Administration (FDA) advisory panel has voted against re-approving the company’s blood cancer drug Blenrep for broader use in combination therapies.

The decision, announced this week, targets the treatment of relapsed or refractory multiple myeloma, a severe form of blood cancer that remains notoriously difficult to treat in advanced stages.

Blenrep, also known by its scientific name belantamab mafodotin, was initially given accelerated approval by the FDA in 2020 for patients who had exhausted other treatment options.

However, in 2022, GSK voluntarily withdrew the drug from the U.S. market after early studies failed to meet the necessary benchmarks in confirmatory trials. The company had hoped to bring the drug back with new data supporting its use alongside standard treatments.

Unfortunately for GSK, the advisory committee remained unconvinced. According to reports from Reuters and Fierce Pharma, the panel expressed serious concerns about Blenrep’s safety profile, particularly its association with ocular toxicity. Many patients in trials experienced vision problems, corneal damage, and other eye-related side effects, raising red flags about the drug’s risk-benefit balance.

Despite promising results in some cases, the committee concluded that the potential dangers outweighed the benefits when combined with other therapies.

GSK stated it respects the panel's decision but remains committed to developing new treatment options for multiple myeloma. The company plans to continue investigating Blenrep in other clinical trials and explore ways to improve its safety.

For now, the FDA’s final decision remains pending, but the advisory vote often heavily influences the agency's course of action.