GSK PLC (LSE:GSK, NYSE:GSK) said its cancer immunotherapy drug, Jemperli (dostarlimab), has been recommended for approval by a key committee at the European Medicines Agency.
Specifically, regulators have endorsed its use in combination with chemotherapy treatments to tackle primary advanced or recurrent endometrial cancer.
The opinion of the Committee for Medicinal Products for Human Use was based on results from the RUBY phase III trial, which showed a 72% reduction in the risk of disease progression or death and a 70% reduction in the risk of death relative to chemotherapy alone.
The European Commission is expected to make a final decision on marketing authorisation by the end of this year. This follows Jemperli's recent approval in the United States and the United Kingdom for the same indication.
"If approved, dostarlimab plus chemotherapy will be the first new treatment option in decades for these patients in the European Union, offering long-awaited new hope for improved long-term outcomes," said Hesham Abdullah, GSK's head of oncology.