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Merck Says FDA Okays New Monotherapy Indication For KEYTRUDA

Merck & Co., Inc. (MRK) said Wednesday that the U.S. Food and Drug Administration approved KEYTRUDA, the company's anti-PD-1 therapy, as monotherapy for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

The company warned that Immune-mediated adverse reactions, which may be severe or fatal, can occur with KEYTRUDA, including pneumonitis, colitis, hepatitis, endocrinopathies, nephritis and renal dysfunction, severe skin reactions, solid organ transplant rejection, and complications of allogeneic hematopoietic stem cell transplantation. Based on the severity of the adverse reaction, KEYTRUDA should be withheld or discontinued and corticosteroids administered if appropriate.

KEYTRUDA can also cause severe or life-threatening infusion-related reactions. Based on its mechanism of action, KEYTRUDA can cause fetal harm when administered to a pregnant woman, the company said.

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