The Food and Drug Administration (FDA) has granted breakthrough therapy designation to GlaxoSmithKline (GSK) for its investigational B-cell mutation agent (BCMA) monoclonal antibody-drug conjugate, GSK2857916, for relapsed and refractory multiple myeloma.
This investigational therapy has also been granted PRIME designation from the European Medicines Agency (EMA) back in October for the treatment of relapsed and refractory multiple myeloma patients whose prior therapy included a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
Both the PRIME and breakthrough therapy designations have been based on an ongoing Phase I trial, the data of which will be presented at the annual meeting of the American Society of Hematology meeting in Atlanta.
“Oncology R&D at GSK is focussed on developing medicines with transformational potential for patients and we are pleased that our investigational antibody-drug conjugate is the first BCMA targeting agent to receive breakthrough therapy and PRIME designation,” stated Axel Hoos, SVP Oncology R&D, GSK. “GSK plans to rapidly advance clinical trials with this promising therapy, alone and in combination with other therapies, to further investigate how GSK2857916 could benefit patients with multiple myeloma. The monotherapy data that we have seen for GSK2857916 support its transformational potential and we look forward to working with regulators as we progress the development programme.”
Additionally, the therapy has received orphan drug designation from the EMA and FDA for multiple myeloma.