GSK PLC (LSE:GSK, NYSE:GSK) has announced significant progress in its oncology pipeline, achieving three milestones.
The European Medicines Agency (EMA) has issued a positive opinion recommending the expanded approval of Jemperli (dostarlimab) with chemotherapy for first-line treatment of advanced or recurrent endometrial cancer.
This decision is based on phase III RUBY trial data demonstrating significant survival benefits, including for patients with mismatch repair proficient (MMRp) tumours, who represent the majority of cases. A final approval decision is expected in early 2025.
In the United States, Jemperli has also received Breakthrough Therapy Designation from the Food and Drug Administration (FDA) for treating locally advanced rectal cancer with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) status.
This follows unprecedented trial results showing a 100% clinical complete response rate, with no detectable tumours post-treatment.
Additionally, GSK'227, a B7-H3-targeted antibody-drug conjugate, has been granted PRIME Designation by the EMA for relapsed extensive-stage small-cell lung cancer.
PRIME (Priority Medicines) is a regulatory initiative designed to accelerate the development and approval of medicines with the potential to address significant unmet needs.
It provides enhanced EMA support, including expedited reviews and early regulatory guidance, to bring promising treatments to patients more quickly.