The European Union’s drug watchdog will investigate a new treatment for a prevalent type of womb cancer in preparation for possible approval in the European market, according to British pharmaceutical giant GlaxoSmithKline PLC on Tuesday.
Dostarlimab, which goes by the brand name Jemperli, has been approved for review by the European Medicines Agency, according to a statement from the manufacturer.
Women with advanced or recurrent endometrial cancer, which develops in the uterine lining, are treated with the monoclonal antibody in conjunction with conventional chemotherapy.
According to the World malignancy Research Fund International, there will be 417,000 new cases worldwide in 2020, making it the sixth most frequent malignancy in women.
Dostarlimab with chemotherapy exhibited a “statistically significant and clinically meaningful benefit” in comparison to a placebo and chemotherapy, according to phase three trial findings published by GSK in March.
Hesham Abdullah, the head of GSK’s oncology development, stated that patients with primary advanced or recurring endometrial cancer “urgently need treatment options.”
He stated in the release that “these patients currently have significant unmet medical needs, and this combination could change the treatment paradigm for this condition.”
Before providing its judgment to the European Commission, which typically approves the watchdog’s recommendations, an EMA committee will formally begin studying the medication, according to GSK.
A regulatory evaluation for the treatment in the United States is also anticipated to begin in the first part of this year, according to the company.
According to GSK, there would be a nearly 40% increase in endometrial cancer incidence by 2040.
According to the company, up to 20% of individuals do not receive a diagnosis until their cancer has advanced.
