April 20, 2000 (Washington) -- The FDA effectively set a new standard of care Thursday for patients suffering from spreading colorectal cancer. It approved a drug called Camptosar as a first-round treatment in combination with currently used chemotherapy. Until now, Camptosar had been used as a second-round treatment for colorectal cancer.
"It is a significant event. There has been no new therapy for [spreading] colorectal cancer in 30 years," Jeff Buchalter, vice president and head of the Global Oncology Franchise at Pharmacia Corp., tells WebMD.
According to the American Cancer Society (ACS), more than 130,000 new cases of colorectal cancer will be diagnosed in the U.S. this year, making it the third most common type of cancer. Although colorectal cancer cases and deaths have decreased over the years, more than 56,000 people will die from the disease this year, projects the ACS. The ACS also advises screening beginning at age 50, and even earlier for those with a personal or family history of the disease.
Camptosar's approval as a first-line treatment was based on two recent studies comparing Camptosar and chemotherapy with chemotherapy alone. A total of more than 1,000 patients participated in the studies, where improvement in survival was the goal.
Both trials showed that the combination regimen improved the average survival time for patients with advanced colorectal cancer by several months.
The most common side effects associated with Camptosar are increased risk of infection, diarrhea, vomiting, and general weakness. The most severe of those is the diarrhea, which can be prolonged and require medical attention.
A greater downside could be the question of what will now be used as second-round treatment. "This is an advance in the treatment of [spreading] colorectal cancer, but clearly we need to continue to find additional therapies," Robert Justice, MD, deputy director of the FDA's Division of Oncology Drug Products, tells WebMD.
While the combination regimen resulted in a survival benefit, the combination still was not a cure, he also points out.