24.06.2024 08:27:57 - dpa-AFX: EMA Accepts GSK's Jemperli Plus Chemotherapy Application For Review

LONDON (dpa-AFX) - GSK plc (GSK.L) Monday said the European Medicines Agency
(EMA) has accepted its application to expand the use of Jemperli in combination
with chemotherapy to treat all patients with primary advanced or recurrent
endometrial cancer.

A decision from the regulator is expected in the first half of 2025.

The application is based on results from Part 1 of the Phase 3 study dubbed
RUBY, in which primary endpoints of progression-free survival (PFS) and overall
survival (OS) were met.

Currently, Jemperli in combination with chemotherapy is approved in the EU for
the treatment of patients who are candidates for systemic therapy with primary
advanced or recurrent endometrial cancer that is mismatch repair deficient
(dMMR) or microsatellite instability-high (MSI-H). If this new application is
approved, dostarlimab would be expanded to all patients with primary advanced or
recurrent endometrial cancer.



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Copyright RTT News/dpa-AFX
Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
GSK PLC LS-,3125 A3DMB5 Frankfurt 18,330 01.07.24 14:26:35 +0,420 +2,35% 17,750 18,040 17,830 17,910

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