Zaltrap is designed to be used in combination with folinic acid, fluorouracil and irinotecan, a commonly used chemotherapy treatment for adults, according to an FDA statement. The drug interferes with blood supply to tumors. It was approved to be used for patients for whom the cancer has spread to other parts of the body or have shown resistance to a chemotherapy using oxaliplatin.
An analyst told Bloomberg it was an encouraging development for the French pharmaceutical company with U.S. offices in Bridgewater, New Jersey, which has suffered setbacks with cancer drugs in recent years. Its breast cancer drug iniparib, acquired when it purchased BiPar Sciences, failed phase 3 clinical trials last year. Clinical trials for Zaltrap for lung cancer and androgen-independent prostate cancer failed to show improved survival.
“Zaltrap isn’t likely to be a large medicine for Sanofi, but getting a cancer drug approved is important for them after a series of setbacks in oncology,” said Pierre Corby, an analyst at Aurel BGC in Paris.
Zaltrap was proven to extend life 1.5 months longer than the current chemotherapy regimen and extend the amount of time patients lived without the cancer progressing by a little more than two months in a randomized clinical study of 1,226 patients. It also reduced the size of the tumor in 20 percent of cases compared with 11 percent who experienced a reduction in tumor size with just the chemotherapy treatment and a placebo.
Colorectal cancer affects the large intestine. Most cancers in this area begin as benign clumps of cells called polyps. About 143,460 Americans will be diagnosed with colorectal cancer in 2012, according to the National Institutes for Health.
Other colorectal cancer drugs approved by the FDA include Avastin, which was approved in 2004, developed by Genentech and marketed by Roche. ImClone and Bristol-Myer Squibb’s drug Erbitux was approved in 2004 under the FDA’s accelerated approval program that allows approval based on early evidence of a product’s effectiveness. Last month, the FDA approved the first genetic test to help some colorectal cancer patients determine if Erbitux would be an effective treatment based on the absence of a gene mutation.