GSK has announced that the US FDA has approved Jemperli (dostarlimab), a programmed death receptor-1 (PD-1) for endometrial cancer.
The product was approved for adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer.
European Commission has also given conditional marketing authorization for women with mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) recurrent or advanced endometrial cancer. Jemperli is the first PD-L1 inhibitor approved for endometrial cancer.
The approval by the European Commission and FDA was based on the GARNET study. GARNET is a multicentre, non-randomized, open-label study. Overall response rate and duration of response were considered as primary endpoints. The overall response rate was 42%, ≥six months duration of response was observed in 93% of patients.
The drug is administered as a 500 mg intravenous infusion every three weeks for four doses, followed by 1,000 mg administered every six weeks.
In the US, the product received the breakthrough designation in May 2019.
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