GSK starts moves to pull FDA approval for blood cancer drug

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