The European Medicines Agency agreed to review the drug, dostarlimab, which has the brand name Jemperli, the company said in a statement.
The monoclonal antibody is used in combination with traditional chemotherapy to treat women with advanced or recurring forms of endometrial cancer, which forms in the inner lining of the uterus.
It is the sixth most common cancer in women, with 417,000 cases reported worldwide in 2020, according to the World Cancer Research Fund International.
Results from a phase three trial released by GSK in March showed that dostarlimab and chemotherapy had a “statistically significant and clinically meaningful benefit” compared to a placebo and chemo, the firm said.
The head of GSK’s oncology development, Hesham Abdullah, said that “treatment options are urgently needed for patients with primary advanced or recurrent endometrial cancer”.
“These patients currently face significant unmet medical needs, and this combination could change the treatment paradigm for this condition,” he said in the statement.
GSK said that an EMA committee will formally begin reviewing the drug before giving its opinion to the European Commission, which usually waves through the watchdog’s recommendations.
The firm said it also expects a regulatory review for the treatment in the United States to start in the first half of this year.
The number of endometrial cancer cases is expected to increase by almost 40 percent by 2040, according to GSK.
Up to 20 percent of patients are not diagnosed until the cancer is at an advanced stage, the company said.
AFP
