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FDA has approved Cyramza (ramucirumab, Eli Lilly) in combination with docetaxel to treat aggressive non-small cell lung cancer.
Lung cancer is the second most common cancer in both men and women and is by far the leading cause of cancer-related deaths in the United States. The American Cancer Society estimates that more than 200,000 Americans will be diagnosed and more than 150,000 will die from lung cancer in 2014. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer and is typically the less aggressive form compared to small cell lung cancer (SCLC)
Cyramza is a recombinant monoclonal antibody that inhibits vascular endothelial growth factor receptor-2 (VEGFR-2). The drug binds the receptor and prevents the binding of normal VEGF ligands ultimately resulting in reduced tumor vascularity and growth.
The approval of Cyramza plus docetaxel is intended for use in patients whose tumor has progressed during or following treatment with platinum based-therapy. Cyramza was reviewed under the FDA’s priority review program. This is Cyrmaza's third FDA approved indication. Earlier this year, the drug was approved as a single agent to treat patients with advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma that did not respond to first-line therapy, and later was approved for use in combination with paclitaxel to treat patients with advanced gastric or GEJ adenocarcinoma.
“Today’s approval is the third indication that Cyramza has received in 2014,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Researc, said in a press release. “The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients.”
The approval is based on the results of a clinical trial, which included 1,253 patients with previously treated and progressive lung cancer. The study was designed to measure overall survival in patients treated with Cyramza plus docetaxel versus docetaxel plus placebo. From the start of treatment, participants treated with Cyramza plus docetaxel survived an average of 10.5 months, compared to an average of 9.1 months for the participants who received placebo plus docetaxel.
In the clinical trial, the most common side effects associated with Cyramza included neutropenia and stomatitis, or inflammation of the lining of the mouth. Cyramza may also cause severe bleeding, blood clots, hypertension and may impair wound healing.
Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.