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US FDA approves Merck's Keytruda for cervical cancer patients

The U.S. Food and Drug Administration approved Merck & Co. Inc.'s Keytruda to treat certain patients with cervical cancer.

Keytruda is now approved for cervical cancer patients whose disease has returned or has spread to other parts of the body on or after chemotherapy and whose disease contains the PD-L1 protein.

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Merck's Keytruda boosts the immune system's ability to kill cancer cells by blocking healthy cells' PD-1 protein from linking up with a partner arm on the surface of cancer cells known as the PD-L1 protein.

The approval is based on a study named Keynote-158, which included a group of 98 patients with recurrent or metastatic cervical cancer. In the trial, 14.3% of the 77 Keytruda-treated patients whose disease contained PD-L1 saw a shrinkage in their tumors, with 2.6% having no detectable levels of the disease and 11.7% of patients' tumors shrinking but not completely going away.

In addition, 91% of patients continued to respond to the treatment for six months or longer. The median duration of response was not yet reached for 11 patients who benefitted from the treatment.

Among the 98 patients, 8% discontinued treatment due to side effects from the therapy. In addition, 39% of patients saw serious side effects, including a deficiency of healthy red blood cells, the development of fistulas, hemorrhage and infections.

Keytruda has now been approved for multiple types of cancers, including skin cancer, lung cancer, head and neck cancer, classical Hodgkin lymphoma, bladder cancer, cancers in the urinary system and stomach cancer.