(dailyRx News) The U.S. Food and Drug Administration has approved a new drug to treat advanced colorectal cancer. The medication extends the lives of those living with colorectal cancer that has spread to other organs (metastasized) by about 45 days.
Zaltrap (ziv-aflibercept) is used in combination with a FOLFIRI (folinic acid, fluorouracil and irinotecan) chemotherapy regimen to treat adults with colorectal cancer that has metastasized (spread) to other sites.
This medication blocks the blood supply that feeds the tumors.
Zaltrap is intended for people with cancers that do not respond to (resistant) or have gotten worse after an oxaliplatin-containing chemotherapy regimen.
“This approval demonstrates the benefits of adding a biological agent, Zaltrap, to a commonly used chemotherapy drug regimen, FOLFIRI,” said Richard Pazdur, MD, 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.”
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 looked at how long patients lived. Those who received the Zaltrap regimen lived about 13.5 months compared to an average of 12 months for those receiving FOLFIRI plus placebo.
Colorectal tumor size also was reduced in about 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.
The drug is being approved with what's known as a Boxed Warning alerting patients and health care professionals that the drug can cause severe and sometimes fatal bleeding, including gastrointestinal bleeding. It can also cause the development of holes in the gastrointestinal tract and make wound healing more difficult.
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.
Zaltrap is manufactured by Bridgewater, N.J.-based sanofi-aventis.