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GSK wins approval for anti-PD-1 antibody Jemperli in endometrial cancer
AnaptysBio earns a $20m milestone payment on approval after originally developing the drug
British pharma company GlaxoSmithKline (GSK) has received US approval for its PD-1 inhibitor Jemperli for the treatment of endometrial cancer.
The Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, following an FDA-approved test.
Cells that are mismatch repair (MMR) deficient often have many DNA mutations and are commonly found in colorectal, gastrointestinal and endometrial cancer.
Endometrial cancer has the highest rate of dMMR among solid tumour types, with approximately 25% bearing this biomarker.
GlaxoSmithKline receives US approval for endometrial cancer treatment
The trial showed an overall response rate of 42.3% and a duration of response of six months or more for 93.3% of participants
GlaxoSmithKline PLC (LON:GSK) said the US Food and Drug Administration (FDA) has approved its treatment for adults with recurrent or advanced endometrial cancer.
JEMPERLI (dostarlimab-gxly) is an antibody that blocks the interaction between the PD-1 receptor with two other proteins that suppress the immune system.
This indication is approved under accelerated approval based on tumour response rate and durability of response, the pharma giant said, so continued approval may depend on results of confirmatory trials.
GlaxoSmithKline s Jemperli secures EU approval following US thumbs up
Fri, 23rd Apr 2021 16:08
(Alliance News) - GlaxoSmithKline PLC said Friday the European Commission has approved Jemperli for for women with recurrent or advanced dMMR endometrial cancer.
Shares in the blue-chip pharma firm were down 0.7% in London on Friday afternoon at 1,339.00 pence each.
The EU s approval follows the regulators in the US green-lighting the treatment on Thursday.
Dostarlimab, the medical name for Jemperli, is indicated for the treatment of adult patients with mismatch repair deficient, dMMR, recurrent or advanced endometrial cancer, as determined by an FDA approved test, that have progressed on or following prior treatment with a platinum containing regimen, GSK noted.