FDA Approves Two New Colorectal Cancer Treatments

The U.S. Food and Drug Administration (FDA) has approved the following two new treatments for advanced colon cancer, Stivarga  and Zaltrap.

Stivarga Approved in September 2012

In September the FDA approved Stivarga to treat patients with colorectal cancer that has progressed after treatment and spread to other parts of the body. Stivarga blocks several enzymes that promote cancer growth.

According to the Centers for Disease Control and Prevention, colorectal cancer is the second most common cancer affecting both men and in women and the second cause of cancer death in men and in women in the United States. The National Institutes of Health estimates 143,460 Americans will be diagnosed with colorectal cancer, and 51,690 will die from the disease in 2012.

The new drug was reviewed under the FDA’s priority review program that provides an expedited six-month review for drugs that offer major advances in treatment or that provide treatment when no adequate therapy exists, according to the FDA news release on the new treatment. Stivarga is being released one month ahead of schedule.

“Stivarga is the latest colorectal cancer treatment to demonstrate an ability to extend patients’ lives and is the second drug approved for patients with colorectal cancer in the past two months,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in FDA’s Center for Drug Evaluation and Research.

The safety and effectiveness of Stivarga were evaluated in a single clinical study of 760 patients with previously treated metastatic colorectal cancer. Patients were randomly assigned to receive Stivarga or placebo in addition to “best supportive care” BSC. Patients received treatment until their cancers progressed or side effects became unacceptable, according to the FDA.

The FDA reported study results that showed patients treated with Stivarga plus BSC lived a median of 6.4 months compared to a median of five months in patients treated with placebo plus BSC. Results also showed patients treated with Stivarga plus BSC experienced a delay in tumor growth for a median of two months compared to a median of 1.7 months in patients receiving placebo plus BSC.

Stivarga has been approved with an alert to patients and health care professionals that severe and fatal liver toxicity occurred in patients treated with Stivarga during clinical studies. The most common side effects reported in patients treated with Stivarga include weakness or fatigue, loss of appetite, hand-food syndrome, diarrhea, mouth sores, weight loss, infection, high blood pressure, and changes in voice volume or quality.

Choosing the most appropriate cancer treatment is a decision that ideally involves the patient, family, and health care team.

Stivarga was developed by Onyx Pharmaceuticals Inc. and by Bayer HealthCare Pharmaceuticals.

Source: The U.S. Food and Drug Administration

Zaltrap Approved August 2012

The U.S. Food and Drug Administration (FDA) approved a new treatment called Zaltrap for use in combination with a chemotherapy regimen to treat adults with colorectal cancer. Zaltrap inhibits the blood supply to tumors. It is intended for patients whose cancer has spread to other parts of the body (metastatic) and whose tumors are resistant to or progressed after the commonly used chemotherapy regimen, FOLFIRI. 

“This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “An improvement in median survival time was noted with the addition of Zaltrap to FOLFIRI, accompanied by an improvement in response rate and a delay in tumor progression and growth,” according to the FDA.

Zaltrap’s safety and effectiveness was evaluated in a randomized clinical study of 1,226 patients with metastatic colorectal cancer whose cancer grew while receiving oxaliplatin-based combination chemotherapy, or whose cancer was removed by surgery but returned within six months after receiving oxaliplatin-based combination chemotherapy for post-surgery (adjuvant) treatment. Participants received treatment until their cancer progressed or side effects became unacceptable.

The study was designed to measure overall survival, or the length of time a patient lived. Patients who were assigned to receive the Zaltrap plus FOLFIRI combination lived an average of 13.5 months compared to an average of 12 months for those receiving FOLFIRI plus placebo. A reduction in tumor size occurred in 20 percent of patients receiving the Zaltrap plus FOLFIRI combination versus 11 percent for those receiving FOLFIRI plus placebo. In addition, the clinical trial demonstrated an improvement in progression-free survival, or the time a patient lived without the cancer progressing. The progression-free survival for patients receiving the Zaltrap plus FOLFIRI combination was 6.9 months compared with 4.7 months for those receiving FOLFIRI plus placebo.

Zaltrap is being approved with an alert to patients and health care professionals that the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding and the development of holes in the gastrointestinal tract. Zaltrap can also make it more difficult for wounds to heal. The most common side effects observed in patients receiving Zaltrap plus FOLFIRI were decreased white blood cell count, diarrhea, mouth ulcers, fatigue, high blood pressure, increased amount of protein in the urine, weight loss, decreased appetite, abdominal pain, and headache.

Choosing the most appropriate cancer treatment is a decision that ideally involves the patient, family, and health care team.

Zaltrap was developed by Sanofi and Regeneron Pharmaceuticals, Inc.

Source: The U.S. Food and Drug Administration

Please take a few moments to comment on this blog and return to the Colon Cancer Foundation's web site to learn more about protecting yourself and your family from this devastating disease. 

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