The U.S. Food and Drug Administration has granted breakthrough therapy status to GlaxoSmithKline’s GSK2857916, an investigational drug used to treat multiple myeloma, the company said Thursday.
FDA gives breakthrough therapy status to drugs that can potentially treat a life-threatening disease and has preliminary clinical evidence that shows an improvement over other existing therapies. If the FDA grants such a status to medicine, the agency speeds up the development and review of the drug and completes the approval process within 60 days of designation.
“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,” said Axel Hoos, senior vice president of the company’s oncology R&D division.
GSK2857916 is an anti-B-cell maturation agent (BCMA) monoclonal antibody-drug conjugate to be used for multiple myeloma patients who have failed at least three other types of treatment, the company said.
The British pharma giant also noted the European health authorities gave it a similar PRIME designation last month to treat relapsed and refractory multiple myeloma patients with three prior lines of therapy. GSK2857916 has also received the orphan drug designation from European and American regulators.
“We are pleased that our investigational antibody-drug conjugate is the first BCMA targeting agent to receive breakthrough therapy and PRIME designation,” Hoos 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.”
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