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.
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.