(News Bulletin 247) – Merck reports that the United States Food and Drug Administration (FDA) has granted full approval to Keytruda for the treatment of patients (adults and children) with high unresectable or metastatic microsatellite instability ( MSI-H) or mismatch repair defect (dMMR) in solid tumors, and having no satisfactory treatment options or alternatives.
The conversion from accelerated approval to full approval is based on results from phase 2 trials involving 504 patients in more than 30 types of cancer. ‘This is the first full approval of an immunotherapy based on a predictive biomarker, regardless of the type of solid tumor’, underlines the laboratory.
“This approval reinforces the important role of Keytruda in certain MSI-Hor dMMR solid tumor patients facing a variety of cancers,” said Dr. Luis A. Diaz, Jr., Chief of the Tumor Oncology Division solids, Memorial Sloan Kettering Cancer Center.
“These data also underscore the need for biomarker testing to identify patients who may be eligible for this therapy,” he adds.
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