British pharmaceutical giant GSK on Tuesday said it has started proceedings to pull US approval for its blood cancer drug Blenrep after it failed to meet the requirements of a late-stage trial.
GSK earlier in November said Blenrep had failed to demonstrate it was more effective than a rival treatment in the market. However, the company maintained that the drug’s benefit-risk profile “remains favourable in this hard-to-treat patient population”.
“Patients responding to belantamab mafodotin-blmf experienced durable clinical benefit, and safety remains consistent with the known safety profile,” it said in a statement.
“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,” said Sabine Luik, GSK chief medical officer.
“We will continue the clinical trial programme and work with the US FDA on a path forward for this important treatment option for patients with multiple myeloma.”
Reporting by Frank Prenesti for Sharecast.com
