Still reeling from Zejula setback, GlaxoSmithKline gets a breather with expanded PD-1 approval
A little less than four months ago, GlaxoSmithKline shepherded the seventh PD-1 across the finish line in Jemperli, winning accelerated approval for a specific subset of patients with endometrial cancer.
On Tuesday, the FDA handed GSK a much broader label.
Jemperli’s accelerated OK was expanded to all adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumors who have progressed or stagnated on earlier therapy. Previously, the drug was only able to be prescribed for endometrial cancer patients with dMMR — i.e endometrial tumors that contains abnormalities that affect the proper repair of DNA inside the cell.
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