GSK's experimental multiple myeloma scores Breakthrough designation with FDA

GlaxoSmithKline is celebrating the FDA’s decision to award its experimental therapy GSK2857916 with Breakthrough Therapy Designation as a monotherapy in patients with multiple myeloma who failed at least three prior lines of treatment, including an anti-CD38 antibody, and are refractory to a proteasome inhibitor and an immunomodulatory agent.

The US regulator’s decision was based upon the results of a Phase 1 study investigating the effects of the treatment in patients with relapsed/refractory multiple myeloma. Data from the trial are due to be unveiled at the 59th annual meeting of the American Society of Hematology.

GSK2857916 is an anti B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate, and was given PRIME designation from the EMA in October in the same indication based on its goal of tackling unmet need. Under these designation’s, the drug will be supported to reach patients as soon as possible.

“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,” commented Axel Hoos, Senior Vice President of Oncology R&D at 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.” 

Matt Fellows