FDA Grants Breakthrough Therapy Designation to GSK’s Multiple Myeloma Treatment

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The agency gave Breakthrough Therapy Designation to GSK’s GSK2857916 monotherapy for the treatment of patients with multiple myeloma who have failed at least three prior lines of therapy.

On Nov. 2, 2017, GlaxoSmithKline (GSK) announced that FDA had granted Breakthrough Therapy Designation to the company’s treatment, GSK2857916, for patients with multiple myeloma who have not responded to other treatments. GSK2857916, an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate, was also granted PRIME designation by the European Medicines Agency in October 2017 for the treatment of relapsed and refractory multiple myeloma whose prior therapy included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. 

These designations will expedite and support the development and review of this treatment. The agencies’ decisions to grant these designations were based on results from a Phase I open-label, dose escalation and expansion study, according to GSK. Data from the trial will be presented at the annual American Society of Hematology meeting in Atlanta on Dec. 11, 2017.

“Oncology R&D at GSK is focused 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 program,” 


Axel Hoos, senior vice-president, Oncology R&D, GSK, said in a press release.

Source: GSK