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The FDA granted a priority review to the supplemental biologics license application for the combination of Keytruda and chemotherapy for the firstline treatment of locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer.
The Food and Drug Administration (FDA) recently granted priority review to the supplemental biologics license application for Keytruda (pembrolizumab) in combination with platinum- and fluoropyrimidine-based chemotherapy for the firstline treatment of patients with locally advanced unresectable or metastatic esophagus cancer and gastroesophageal junction cancer, according to the manufacturer’s agent, Merck.
“Patients with newly diagnosed esophageal and (gastroesophageal junction) cancer face an aggressive disease with a poor prognosis, despite the currently available treatment options,” said Dr. Vicki Goodman, vice president of clinical research at Merck Research Laboratories, in a company-issued press release. “We look forward to working with the FDA to bring a new option to patients in the first-line setting.”
The filing was based on results from the randomized, double-blind phase 3 KEYNOTE-590 trial, in which Keytruda plus chemotherapy demonstrated significant improvements in overall survival and progression-free survival (or time of treatment until disease progression) versus chemotherapy in patients with locally advanced unresectable or metastatic esophageal and gastroesophageal junction cancer, regardless of PD-L1 expression status and tumor histology.
Keytruda is currently approved in the United States, China and Japan as a single-agent treatment for the second line treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1.
The agency is set to make its decision on whether to approve the drug in combination with chemotherapy for this use by April 13, 2021.
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