December 12, 2014 I The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).
The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. The National Cancer Institute estimates that 224,210 Americans will be diagnosed and 159,260 will die from lung cancer in 2014.
Cyramza works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has grown (progressed) during or following treatment with platinum-based chemotherapy, and it is to be used in combination with docetaxel, another type of chemotherapy.
“Today’s approval is the third indication that Cyramza has received in 2014,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients.”
On April 21, the FDA approved Cyramza as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. On November 5, the FDA expanded Cyramza’s use to treat patients with advanced gastric or GEJ adenocarcinoma to include paclitaxel, another chemotherapy drug.
The approval of Cyramza plus docetaxel for metastatic NSCLC is based on a clinical study of 1,253 participants with previously treated and progressive lung cancer. Study participants were randomly assigned to receive Cyramza plus docetaxel or a placebo plus docetaxel. Treatment was given until disease progression or development of intolerable side effects.The trial was designed to measure overall survival, the length of time a participant lived before death. Results showed that half of the participants treated with Cyramza plus docetaxel survived an average of 10.5 months from the start of treatment, compared to an average of 9.1 months from the start of treatment for half of the participants who received placebo plus docetaxel.
The most common side effects associated with Cyramza plus docetaxel observed in the clinical study included a decrease in infection-fighting white blood cells called neutrophils (neutropenia) fatigue and inflammation of the lining of the mouth (stomatitis). Cyramza can cause severe bleeding, blood clots, elevation in blood pressure and may impair wound healing.
The FDA reviewed Cyramza’s application for this new use under the agency’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.
Cyramza is marketed by Indianapolis-based Eli Lilly.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE: FDA
Post Views: 171
December 12, 2014 I The U.S. Food and Drug Administration today expanded the approved use of Cyramza (ramucirumab) to treat patients with metastatic non-small cell lung cancer (NSCLC).
The most common type of lung cancer, NSCLC occurs when cancer cells form in the tissues of the lung. The National Cancer Institute estimates that 224,210 Americans will be diagnosed and 159,260 will die from lung cancer in 2014.
Cyramza works by blocking the blood supply that fuels tumor growth. The drug is intended for patients whose tumor has grown (progressed) during or following treatment with platinum-based chemotherapy, and it is to be used in combination with docetaxel, another type of chemotherapy.
“Today’s approval is the third indication that Cyramza has received in 2014,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “The commitment to study Cyramza in a variety of malignancies provides important treatment options to patients.”
On April 21, the FDA approved Cyramza as a single agent to treat patients with advanced stomach cancer or gastroesophageal junction (GEJ) adenocarcinoma, a form of cancer located in the region where the esophagus joins the stomach. On November 5, the FDA expanded Cyramza’s use to treat patients with advanced gastric or GEJ adenocarcinoma to include paclitaxel, another chemotherapy drug.
The approval of Cyramza plus docetaxel for metastatic NSCLC is based on a clinical study of 1,253 participants with previously treated and progressive lung cancer. Study participants were randomly assigned to receive Cyramza plus docetaxel or a placebo plus docetaxel. Treatment was given until disease progression or development of intolerable side effects.The trial was designed to measure overall survival, the length of time a participant lived before death. Results showed that half of the participants treated with Cyramza plus docetaxel survived an average of 10.5 months from the start of treatment, compared to an average of 9.1 months from the start of treatment for half of the participants who received placebo plus docetaxel.
The most common side effects associated with Cyramza plus docetaxel observed in the clinical study included a decrease in infection-fighting white blood cells called neutrophils (neutropenia) fatigue and inflammation of the lining of the mouth (stomatitis). Cyramza can cause severe bleeding, blood clots, elevation in blood pressure and may impair wound healing.
The FDA reviewed Cyramza’s application for this new use under the agency’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and, if approved, would offer significant improvement compared to marketed products.
Cyramza is marketed by Indianapolis-based Eli Lilly.
The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
SOURCE: FDA
Post Views: 171
