GlaxoSmithKline said on Thursday that its investigational BCMA antibody-drug has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) for monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy.
It also includes an anti-CD38 antibody and are refractory to a proteasome inhibitor and an immunomodulatory agent. In October, the European Medicines Agency (EMA) granted PRIME designation to GSK2857916 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. GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate.
GSK2857916 has also received orphan drug designation from the EMA and FDA for multiple myeloma, GSK said.
Axel Hoos, SVP Oncology R&D, GSK said: “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. 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.”