FDA Approves New Treatment for Colorectal Cancer

The FDA has recently approved pembrolizumab, which is a treatment for colorectal cancer, specifically MSI-H and dMMR colorectal cancer. This approval comes after the release of positive results of the KEYNOTE-177 trial.

About Colorectal Cancer

Colorectal cancer is an umbrella term for any cancer that affects the colon and rectum. It is fairly common, affecting one of every 21 males and one of every 23 females. It causes symptoms like fatigue, iron deficiency, discolored or bloody stool, constipation, changes in bowel movements, feeling full, pain in the abdomen, weight loss, diarrhea, and bloating in the abdomen. While doctors are unsure as to what exactly causes these symptoms, they do know that there are a number of risk factors associated with this cancer. These include a poor diet, older age, having other forms of cancer, drinking a lot of alcohol, smoking, obesity, no physical activity, a family history of this cancer, being affected by IBD, and polyps in the colon or rectum. While treatment options differ between affected individuals, based on various criteria, the options include surgery, chemotherapy, radiation, and ablation.


This drug was officially approved on June 29 for the treatment of unresectable or metastatic microsatellite instability-high and mismatch repair deficient colorectal cancer. It is recommended to be administered every three weeks if given 200 mg or every six weeks if given 400 mg.

It was the KEYNOTE-177 trial, which was conducted internationally throughout multiple sites and was open-label, randomized, and active-controlled. 307 patients were given either chemotherapy or pembrolizumab at a 1:1 rate.

Researchers looked for progression free survival and overall survival. In terms of results, the former was 16.5 months for pembrolizumab and 8.2 months for chemotherapy. The data for overall survival is not yet mature. Another positive was the low number of adverse events (AE) experienced. Less than 20% of participants reported an AE.

This new treatment will hopefully be able to better the lives of those with colorectal cancer. Click here to read more about this approval.

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