The U.S. Food and Drug Administration (FDA) on Friday approved the expanded use of Merck & Co’s blockbuster immunotherapy Keytruda in combination with chemoradiotherapy to treat newly diagnosed patients with a type of advanced cervical cancer.
The Keytruda combination was approved for patients with cervical cancer who had not previously received surgery, radiation, or systemic therapy, FDA said.
This makes Keytruda plus chemoradiotherapy the first anti-PD-1-based immunotherapy combination approved in the U.S. as a treatment for newly diagnosed patients with a certain type of cervical cancer, Merck said.
Merck’s top-selling drug Keytruda helps the body’s own immune system fend off cancer by blocking a protein called PD-1. It has been approved to treat more than ten kinds of cancer.
Cervical cancer, which forms in the cells lining the cervix, is the fourth most common cancer in women globally, according to the World Health Organization.
The approval was based on data from a late-stage trial of 1,060 patients in which the drug combination reduced the risk of cancer progression or death by 41 per cent when compared to treatment with chemoradiotherapy alone, Merck said.
Keytruda is already approved as a combination therapy and a monotherapy to treat patients with two other types of cervical cancers.
The drug, which is set to lose certain U.S. patents toward the end of the decade, was expected to bring in sales of nearly $25-billion in 2023.