GlaxoSmithKline: Myeloma Therapy Gets FDA Breakthrough Therapy Designation
GlaxoSmithKline PLC (GSK.LN) said Thursday that it has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for an antibody to treat patients with multiple myeloma who have failed at least three prior lines of therapy.
The therapy--GSK2857916--has also received orphan drug designation from the European Medicines Agency and FDA for multiple myeloma, the pharmaceutical giant said.
Glaxo said it plans to advance clinical trials with this therapy, alone and in combination with other therapies, to further investigate how GSK2857916 could benefit patients with multiple myeloma.
Write to Ian Walker at ian.walker@wsj.com; @IanWalk40289749
(END) Dow Jones Newswires
November 02, 2017 04:11 ET (08:11 GMT)