FDA approves Keytruda as first-line therapy for MSI-H/ dMMR metastatic colorectal cancer

The U.SFDAtoday approved Keytruda (pembrolizumab) as a first-line treatment for patients with microsatellite instability (MSI-H) or mismatch edimen (dMMR) metastasiscolorectal cancerThe frequency of MSI-H varies depending on tumor type and stage, with about 5% of metastatic colorectal cancer patients having MSI-H or dMMR tumorsThe approval is based on the latest results of a multi-center, open-label randomized trialThe study showed that the median PFS in the Keytruda group was 16.5 months and the median PFS in the standard care group was 8.2 monthsDr Richard Pazdur, director of the FDA's Center for Oncology Excellence, said: "Metastatic colorectal cancer is a serious and life-threatening disease with a poor prognosisBoth the chemical and biological therapies currently available are significantly toxic,immunotherapy approved as a first-line therapy marks a paradigm shift in treatment."Keytruda is able to target PD-1/PD-L1 on human immune cells and certain cancer cellsBy blocking this pathway, Keytruda can help the body's immune system fight cancer cells and benefit patients with MSI-H or dMMR metastatic colorectal cancerThe FDA has previously approved Keytruda for other types of cancer