GSK PLC (LSE:GSK, NYSE:GSK) has started the withdrawal process for US marketing authorisation for Blenrep following a request from the US Food and Drug Administration (FDA).
The request followed the previously announced outcome of the DREAMM-3 phase III trial which failed to meet FDA requirements, wiping around £1.7bn of the FTSE 100-listed drugs group’s share price.
Blenrep was deemed no better than the current standard of care in helping people with hard-to-treat multiple myeloma, a type of bone marrow cancer.
GSK said it will continue the DREAMM programme with results from the additional trials expected in the first half of 2023.
Sabine Luik, chief medical officer, said: "We respect the Agency's approach to the accelerated approval regulations and associated process.
“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."