FDA approves the first immunotherapy for colorectal cancer patients


Today, the US Food and Drug Administration (FDA) has approved the first immunotherapy for patients with metastatic colorectal cancer. This is the first approved immunotherapy for this group of patients as first-line treatment which is given to patients without chemotherapy as well, and Keytruda (pembrolizumab) injection works for injection. Intravenous treatment of patients with MSI-H or instability Colon Cancer And the rectum.

FDA approves cancer medicine
FDA approves cancer medicine

Colorectal tumors have abnormalities that affect the correct repair of intracellular DNA, and about 5% of patients with metastatic colorectal cancer have tumors.

Richard Fosdor, director of the Center for Oncology at the Food and Drug Administration (FDA), said metastatic colorectal cancer is a serious life-threatening disease with poor prognosis, and the current treatment available with other chemotherapy and biology groups is associated with significant toxicity, so the availability of a non-chemotherapy option for patients is A marked paradigm shift in treatment. ”

Keytruda works by targeting the cellular pathway of proteins present in the body’s immune cells and some cancerous cells.

By blocking this course, Keytruda may help the body’s immune system fight cancer cells and provide benefit in patients with colorectal cancer, and the US Food and Drug Administration previously approved Keytruda to treat other types of cancer.

The US Food and Drug Administration’s approval of this indicator was based on the results of an internationally controlled, open-ended, multicenter randomized controlled trial, and Keytruda compared with chemotherapy in 307 patients with metastatic colorectal cancer, and the study showed statistically significant improvement in survival

Common side effects of Keytruda include fatigue, muscle and bone pain, decreased appetite, itchy skin (itching), diarrhea, nausea, rash, fever (fever), cough, difficulty breathing (shortness of breath), constipation, pain, and abdominal pain.

Keytruda can cause serious conditions known as immune-mediated side effects, including inflammation of healthy organs such as the lungs (pneumonia), colon (colitis), liver (hepatitis), endocrine (endocrine), and kidneys (nephritis).

Therefore patients with severe or life-threatening reactions by injection should stop taking Keytruda, and pregnant women should be advised that the drug may cause harm to the developing fetus, and women who are breastfeeding should not take Keytruda because it may harm a nursing baby Natural.

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