keytruda a new monotherapy indication of merck received approval form fda

Keytruda A New Monotherapy Indication of Merck Received Approval Form FDA


The USFDA has approved Merck & Co’s anti-PD-1 therapy – Keytruda (pembrolizumab). This therapy is for the treatment of patients having metastatic or recurrent locally advanced squamous cell carcinoma of the esophagus of which tumors indicates PD-L1. Previously, there were few options for the patient suffering from an advanced stage of esophageal cancer. Specifically, when their disease starts progressing. After this approval from the FDA, this monotherapy is a reliable option for many patients and physicians in the United States. In addition, Keytruda is a first anti-PD-1 therapy. This therapy can be followed for the treatment of a patient, that is treated with metastatic or recurrent locally advanced squamous cell carcinoma of the esophagus of which tumors indicates PD-L1. The PD-L1 indicates Combined Positive Score [CPS] ≥10.

However, Keytruda may generate immune-mediated adverse reactions. That may be fatal or severe. These adverse reactions may include, hepatitis, colitis, pneumonitis, endocrinopathies, renal dysfunction and nephritis, solid organ transplant rejection, severe skin reactions, and complications of allogeneic hematopoietic stem cell transplantation. On the basis the severity, the Keytruda can be discontinued or withheld, and if appropriate, then corticosteroids administered. In addition, according to the mechanism of Keytruda, it can generate harmful effects to the fetus, if administered to a pregnant woman.

The approval of Keytruda is based on KEYNOTE-181 data. KEYNOTE-181 is an open-label, active-controlled, randomized, and a multicenter clinical trial. There are 628 patients enrolled with this trial. Keytruda supports to find and fight against cancer cells by raising the immunity power of the patient body. Besides this, as Keytruda is a manmade monoclonal antibody which blocks the interaction in between PD-L1 and PD-L2, and PD-1 and its ligands. This is done by activating T lymphocytes. However, T lymphocytes can damage both the tumor cells and healthy cells. In Merck, over 1,000 trials are working and studying Keytruda to understand the benefits and effects of Keytruda better.

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