(Alliance News) - GlaxoSmithKline PLC on Friday said the European regulator has adopted a positive opinion recommending dostarlimab, one of the final steps in the marketing authorisation procedure.
Dostarlimab is an anti-programmed-death-1 monoclonal antibody, which was recommended by the Committee for Medicinal Products for Human Use of the European Medicines Agency for use as monotherapy in women with mismatch repair deficient endometrial cancer, who have progressed on or following prior treatment with a platinum containing regimen.
The Brentford, England-headquartered pharmaceutical company said the application is based on data from the Garnet study.
Meanwhile, dostarlimab is also under review with the US Food & Drug Administration for the treatment of women with recurrent or advanced endometrial cancer. Dostarlimab is not currently approved for use anywhere in the world.
"This positive opinion brings us one step closer to providing dostarlimab as a new treatment option to women with endometrial cancer in Europe with the hope of improving outcomes. If approved by the European Commission, dostarlimab would be the first anti-PD-1 therapy approved for endometrial cancer in Europe," said Axel Hoos, senior vice president & head of Oncology Research & Development at GSK.
GSK shares were trading 0.4% lower in London on Friday at 1,211.00 pence each.
By Evelina Grecenko; evelinagrecenko@alliancenews.com
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Glaxosmithkline (GSK)
