GSK gets USFDA nod for Jemperli to treat advanced solid Tumours

I’m excited about GSK’s second oncology USFDA approval this year, and the new treatment option it provides for these patients.”

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USFDA
Picture: Pixabay

Last Updated on August 21, 2021 by The Health Master

GlaxoSmithKline (GSK) has announced that the US Food and Drug Administration (USFDA) approved a new indication for Jemperli (dostarlimab-gxly), a programmed cell death receptor-1 (PD-1) blocking antibody, for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced solid tumours.

The continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s), a statement from the company said.

Speaking on the development, Dr Hal Barron, Chief Scientific Officer and President, R&D, GSK, said, “For patients with tumours expressing the dMMR biomarker, there continues to be a significant need for new and effective treatments.

I’m excited about GSK’s second oncology USFDA approval this year, and the new treatment option it provides for these patients.”

The statement also mentioned that the mismatch repair-deficient tumours contain abnormalities that affect the proper repair of DNA when copied in a cell. In the US, the prevalence of dMMR across patients with solid tumours has been estimated at 14 per cent.

The mismatch repair-deficient status is a biomarker that has been shown to predict response to immune checkpoint blockade with PD-1 therapy. Tumours with this biomarker are most commonly found in endometrial, colorectal and other gastrointestinal cancers, but may also be found in other solid tumours.

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