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FDA Approval Round Up: Keytruda, Opdivo Add Claims

 
• By Michael Cipriano

Cancer supplements took center stage for US FDA this week, but OptiNose Inc.'s corticosteroid Xhance also took a bow.

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Merck & Co. Inc.'s Keytruda (pembrolizumab) reached double digits for FDA-approved indications, with the agency most recently backing the programmed-death receptor for the treatment of gastric cancer.

Keytruda specifically gained accelerated approval Sept. 22 for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 with disease progression on or after two or more prior lines of therapy

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