Health Canada grants full approval to Jemperli (dostarlimab-gxly) for adult patients with recurrent or advanced mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) endometrial cancer. - GSK
Health Canada has granted full approval to dostarlimab-gxly (Jemperli) monotherapy for adult patients with recurrent or advanced mismatch repair–deficient (dMMR) or microsatellite instability–high (MSI-H) endometrial cancer who have progressed on or after treatment with a platinum-based regimen
The agent had previously received a Notice of Compliance with conditions (NOC/c) for this patient population from Health Canada in December 2021. The conversion of this indication to full approval was supported by additional data from the A1 expansion cohort of the phase 1 GARNET trial (NCT02715284). Long-term findings demonstrated a confirmed objective response rate (ORR) of 45.5% (95% CI, 37.1%-54.0%) in patients with dMMR/MSI-H endometrial cancer. At a median follow-up of 27.6 months, the median duration of response (DOR) was not reached (range, 1.18+, 47.21+ months).
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