16th Oct 2023 08:09
(Alliance News) - GSK PLC on Monday said its monoclonal antibody Jemperli is closer to becoming the first new frontline treatment option in the EU in decades for a certain form of endometrial cancer.
The Brentford, London-based pharmaceutical company said Jemperli, or dostarlimab, when combined with chemotherapy, received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use as frontline treatment for mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer.
GSK said the CHMP opinion is one of the final steps before a potential marketing authorisation decision by the European Commission, which it expects by the end of the year.
Hesham Abdullah, senior vice president of global head oncology of GSK's research & development unit, said: "We are pleased with this positive CHMP opinion and the potential for dostarlimab with chemotherapy to treat patients with this very challenging form of endometrial cancer. If approved, dostarlimab plus chemotherapy will be the first new treatment option in decades for these patients in the EU, offering long-awaited new hope for improved long-term outcomes. This opinion further reinforces our confidence in dostarlimab's important role in the immuno-oncology treatment landscape."
GSK's application for authorisation is based on interim analysis results from a phase 3 trial which showed a 72% reduction in the risk of disease progression or death among patients with mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer.
GSK shares were 0.6% lower at 1,501.00 pence each on Monday morning in London.
By Tom Budszus, Alliance News reporter
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