March 23, 2021

The U.S. FDA has approved a new indication for Keytruda® (pembrolizumab), manufactured by Merck. The drug is now indicated for use in combination with platinum- and fluoropyrimidine-based chemotherapy to treat locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) carcinoma that is not amenable to treatment with surgical resection or definitive chemoradiation.

Esophageal cancer begins in the esophagus, which is the tube that connects the throat to the stomach, while GEJ cancers begin in the area where the esophagus meets the stomach. Cancers that begin in the esophagus or GEJ often have poor survival rates – particularly when the disease has spread from the site of origin to become locally advanced or metastatic.

In a clinical study, Keytruda plus fluorouracil and cisplatin reduced patients’ risk of death by 27% and the risk of disease progression or death by 35% compared to fluorouracil and cisplatin alone. It also delivered an objective response rate of 45% versus 29% with only fluorouracil and cisplatin.

Recommended dosing under the new indication is 200mg once every three weeks or 400mg once every six weeks, administered via 30-minute intravenous infusion, until either disease progression or unacceptable toxicity occur.

First FDA approved in 2014, Keytruda is indicated to treat more than a dozen different types of cancer, including an esophageal cancer indication for use as a single agent in patients who have undergone systemic therapy and have squamous cells that express PD-L1.

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