LONDON (dpa-AFX) - GSK plc (GSK, GSK.L) said that it has initiated the process for withdrawal of the US marketing authorization for blood cancer drug Blenrep following the request of the US Food and Drug Administration.
The request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the US FDA Accelerated Approval regulations.
Blenrep is a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.
Multiple myeloma is the second most common blood cancer in the US and is generally considered treatable but not curable.
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