GlaxoSmithKline cancer treatment gets FDA breakthrough therapy designation

GlaxoSmithKline said on Thursday that it has received US FDA breakthrough therapy designation - designed to expedite the development and review of drugs intended to treat a serious condition - for an antibody to treat patients with multiple myeloma who have failed at least three prior lines of therapy.

The GSK2857916 therapy has also received orphan drug designation from the European Medicines Agency and the FDA for multiple myeloma.

Axel Hoos, senior vice president for Oncology, R&D, said: "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."

Glaxo said that data from its ongoing trial will be presented on 11 December at the 59th annual meeting of the American Society of Hematology meeting in Atlanta.

At 0855 GMT, the shares were down 0.9% to 1,339p.