Merck & Company (MRK) said on Friday the U.S. Food and Drug Administration has approved Keytruda (pembrolizumab) for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

“Historically, advanced gastric cancer has been particularly challenging to treat, and new treatment options are needed for these patients,” said Charles Fuchs, lead investigator and director of Yale Cancer Center.

He said the results observed in the diverse population of heavily pretreated advanced gastric or GEJ patients from the Keynote-059 clinical trial showed that pembrolizumab in the third-line setting has the potential to shift in how to care for certain patients facing this difficult-to-treat disease.

Merck said this indication was approved under the FDA’s accelerated approval regulations based on tumor response rate and durability of response, with continued approval contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck shares were 0.7% lower in regular-hours trading.


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