FDA Approves New Monoclonal Antibody For Colon Cancer Treatment

FDA Approves New Monoclonal Antibody For Colon Cancer Treatment

The U. S. Food and Drug Administration (FDA) has recently approved a new drug for colon cancer. According to an announcement on the FDA website, the approval has been granted for “Ramucirumab (CYRAMZA®, Eli Lilly and Company) for use in combination with FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC) whose disease has progressed on a first line bevacizumab-, oxaliplatin- and fluoropyrimidine-containing regimen.” Metastatic cancer refers to aggressive cancer that has spread to other parts of the body.

Ramucirumab blocks the activity of a molecule called vascular endothelial growth factor (VEGF), a receptor discovered in 1983. VEGF helps the body to produce blood vessels, a process called angiogenesis, and even though it usually has beneficial effects in the body, too much of it can cause diseases like cancer since blood vessels provide nourishment to growing cancer cells. Blocking VEGF in cancer cells can therefore be a strategy for stopping tumor growth.

Ramucirumab is a monoclonal antibody, which means that it is a laboratory-produced molecule designed to attack cancer cells by blocking the human VEGF- receptor 2 (VEGF-R2), the protein to which VEGF normally binds to cause production of blood vessels.

The FDA based their decision for approval on results from a Phase III clinical trial that included people with metastatic colorectal cancer who had continued to grow during or within 6 months after they stopped using the medications bevacizumab-, oxaliplatin- and fluoropyrimidine as a combination chemotherapy.

A total of 1,072 people received FOLFIRI plus placebo or FOLFIRI plus ramucirumab. The researchers administered the treatments every 2 weeks, giving patients ramucirumab by intravenous infusion. They continued to treat patients with ramucirumab unless they observed it was no longer effective in cancer treatment or if the side effects were too severe.

The results demonstrated that survival rates were statistically significant between the two groups under analysis: more patients survived if they received FOLFIRI plus ramucirumab (13.3 months longer) compared to those who received FOLFIRI plus placebo. The addition of ramucirumab also increased the amount of time that patients survived without having cancer progression: 5.7 months for people treated with FOLFIRI plus ramucirumab compared to 4.5 months in those receiving FOLFIRI plus placebo.

This approval adds an important new treatment in the fight against colorectal cancer. In men and women, colorectal cancer is the third most commonly diagnosed cancer as well as the third leading cause of cancer death.

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