US regulators have cleared GSK Plc’s Jemperli drug in combination with chemotherapy as a frontline treatment for a particular type of endometrial cancer, boosting the drug’s blockbuster potential, according to a company press release.
European and US regulators greenlit the use of Jemperli in April 2021 and Monday’s expanded approval represents the first new frontline treatment option in decades for this type of cancer.
The US Food and Drug Administration didn’t immediately respond to comment.
The approval comes after a recent study found the drug, when combined with chemotherapy, reduced disease progression and the risk of death in 71% of patients who have a specific type of tumor that affects about a third of people with endometrial cancer.
“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” Hesham Abdullah, global head of oncology development at GSK, said in a statement. “Today’s expanded approval of Jemperli redefines the treatment landscape.”
GSK has invested heavily in the drug, also known as dostarlimab, and is seeking to eventually show it could be used to treat several types of cancer.
Endometrial cancer is found in the inner lining of the uterus and is the most common gynecologic cancer in developed countries. About 15% to 20% of patients will already have advanced cancer at the time of diagnosis, the company has said.
