09:21 AM EST, 12/16/2024 (MT Newswires) -- GSK (GSK) said Monday that the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended expanding the approval of its experimental drug, Jemperli, in combination with chemotherapy, as a first-line treatment for adults with primary advanced or recurrent endometrial cancer who are candidates for systemic therapy.

The company said the recommendation follows positive results from a phase III trial, which showed significant benefits in progression-free and overall survival with the combination treatment.

The final approval decision from the European Commission is expected in Q1 2025, the company said .

Separately, GSK said the US Food and Drug Administration granted Breakthrough Therapy Designation for Jemperli to treat patients with locally advanced, mismatch repair deficient instability-high rectal cancer.