Abstract
FDA’s May 23 announcement of a newly approved tissue- and site-“agnostic” indication for pembrolizumab marks a first for the agency and is seen as an important milestone in cancer treatment. “This approval is a game-changer,” said Patrick Kiel, clinical pharmacist for the oncology–precision genomics program at Indiana University Health’s Melvin and Bren Simon Cancer Center in Indianapolis. Pembrolizumab, a human programmed death receptor-1 (PD-1)–blocking antibody, is marketed as Keytruda by Merck. The product was initially approved in 2014 for the treatment of advanced melanoma. The new indication is for use in patients with inoperable or metastatic solid tumors characterized by “microsatellite instability-high” or mismatch repair deficiency that have progressed despite past treatment, according to the labeling. In addition, the labeling states that the patients should have “no satisfactory alternative treatment options.” Microsatellite instability can result from defects in the mismatch repair process during DNA replication, altering the number of repeated sequences.
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Schedule a callMore From: American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
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