GlaxoSmithKline plc (GSK) has a breakthrough.
The pharmaceutical company received FDA approval Thursday, Nov. 2, for fast-track development of a new experimental blood cancer drug currently labeled GSK2857916, the company said in a statement.
The FDA gave the drug "breakthrough therapy designation," meaning regulatory review will be faster than it typically is for other drugs. The treatment offers monotherapy in patients with multiple myeloma who have failed at least three prior lines of therapy and are refractory to a proteasome inhibitor and an immunomodulatory agent, GSK said.
The FDA's decision follows a similar action from the European Medicines Agency, which approved development for GSK2857916 last month. Both approvals follow promising Phase I clinical trial results, which are scheduled to be announced in December.
GSK sold its marketed cancer drugs to industry peer Novartis AG (NVS) in 2015, but the company continues to fund early-stage research. Oncology remains an option to add to GSK's pharmaceuticals business.
"GSK plans to rapidly advance clinical trials with this promising therapy, alone and in combination with other therapies," the company said.
GSK shares were lower 0.5% to $36.02 premarket Thursday.
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