GSK’s Jemperli approved in EU as treatment for endometrial cancer
Betsy Goodfellow | December 11, 2023 | News story | Medical Communications | EU, GSK, Jemperli, Oncology, endometrial cancer
GSK has announced that the European Commission (EC) has granted marketing authorisation to Jemperli (dostarlimab) in combination with carboplatin-paclitaxel chemotherapy, for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer.
With this new authorisation for this indication, the EC’s conditional approval for Jemperli as a monotherapy for adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with platinum-containing regimen has now been converted to a full approval.
This authorisation follows interim analysis results from the dMMR/MSI-H population of part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase 3 trial, which demonstrated a robust median duration of follow up of ≥ 25 months. The trial also met its primary endpoint of investigator-assessed progression-free survival and demonstrated a statistically significant and clinically meaningful benefit in patients treated with the drug in combination with carboplatin and paclitaxel.
Hesham Abdullah, senior vice president, global head oncology R&D, GSK, commented: “People living with this type of endometrial cancer typically experience disease progression and poor long-term outcomes with current standard of care. With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey. We are proud of the recent approvals for Jemperli as we believe that it continues to transform the frontline endometrial cancer treatment landscape and shows promise as a foundational immuno-oncology therapy.”
Betsy Goodfellow
Related Content
GSK’s Jemperli accepted for FDA review for endometrial cancer treatment
GSK has announced that the US Food and Drug Administration (FDA) has accepted its supplemental …
GSK shares results from phase 3 trial for gonorrhoea treatment
GSK has announced positive results from its phase 3 EAGLE-1 trial for gepotidacin, a potential …
GSK’s meningococcal vaccine candidate accepted for FDA review
GSK has announced that the US Food and Drug Administration (FDA) has accepted for review …
