GSK's Blenrep Shows Significant Reduction in Mortality Risk in Combination Therapy, Paving the Way for Regulatory Reapproval

Intelligent Finance APP learned that British pharmaceutical giant GlaxoSmithKline (GSK.US) stated that when its blood cancer drug was used in combination with another cancer treatment drug, it significantly reduced the risk of death in cancer patients, further increasing the likelihood of prior FDA approval.European Medicines AgencyAnnouncement of the Withdrawal of Anticancer DrugsBlenrepThe prospect of being reintroduced to the market.

GSK Says Blenrep, in Combination with Another Cancer Therapy Called BorDex, Extended Lives of Patients with Relapsed Myeloma. The British pharmaceutical giant stated that the results of the late-stage clinical trial could be "potentially transformative" for patients.

Earlier this year, GSK said that when Blenrep is used in combination with another cancer treatment drug called PomDex, it helps slow disease progression.

The latest trial results released on Thursday may help convince regulators of the drug's efficacy, which is a crucial part of GSK's push into cancer treatment, after the company's ambitions faced setbacks in 2022.

At the time, the U.S. Food and Drug Administration (FDA) stated that, in view of the failure of the myeloma clinical trial, the anticancer drug should be forced to withdraw from the market. The European Medicines Agency also recommended that the conditional approval of the drug should not be extended. It is reported that GSK has now resubmitted the drug marketing application in the United States, Europe, and Japan.

For GSK's performance outlook, Blenrep has been removed from the pharmaceutical giant’s own projections. However, if the therapy receives formal regulatory approval, GSK estimates its annual sales could exceed £3 billion (approximately $3.8 billion).

Blenrep (Generic Name: Belantamab Mafodotin) is an antibody-drug conjugate (ADC) developed by GSK for the treatment of relapsed or refractory multiple myeloma. However, due to its failure to demonstrate efficacy as a monotherapy in pivotal clinical trials and the high incidence of corneal toxicity, it was required by the FDA and EMA to be withdrawn. Nevertheless, with the publication of combination therapy results, Blenrep's reapplication may be reconsidered by regulatory authorities, particularly under certain safety monitoring conditions.