GSK will stop selling its blood cancer drug Blenrep in the US, it said yesterday, in another setback for the British drugmaker’s oncology business.
The company had said this month that Blenrep had failed the main goal of a key study designed to show it was better than an existing treatment on the market, stoking fears that regulatory approval could be rescinded by the US Food and Drug Administration (FDA).
Yesterday, GSK said it has begun the process to withdraw Blenrep’s marketing authorisation in the country but would continue trial programmes for the drug, adding that some patients would have the option to enroll for continued access to the treatment.
The drugmaker’s shares were down 0.2 per cent at 1345 GMT.
“We will continue the DREAMM clinical trial programme and work with the US FDA on a path forward for this important treatment option for patients with multiple myeloma,” Sabine Luik, Chief Medical Officer, GSK, said in a statement.
Marketing of Blenrep continues in the 17 other countries — mostly in the European Union — where it has been approved, a GSK official said, but the US move will raise doubts about the drug’s future.
The company is still discussing the latest clinical data with EU health authorities, the official said.
Edits by EP News Bureau