FDA APPROVES AMGEN'S VECTIBIX FOR COLORECTAL CANCER

The FDA has approved Amgen's Vectibix (panitumumab) for the treatment of metastasized colorectal cancer following standard chemotherapy. Vectibix, a monoclonal antibody that binds to a protein called epidermal growth factor receptor (EGFR) on some cancer cells, received an accelerated approval after showing effectiveness in slowing tumor growth and, in some cases, reducing the size of the tumor.

The FDA approved Vectibix on the basis of the results of a randomized, controlled clinical trial of 463 patients with metastatic cancer of the colon and the rectum after undergoing treatment with chemotherapy drugs fluoropyrimidine, oxaliplatin and irinotecan.

The mean time to disease progression or death in patients receiving Vectibix was 96 days versus 60 days in patients receiving the best standard supportive care. In addition, 8 percent of the patients on Vectibix experienced a tumor shrinkage that in some cases exceeded 50 percent of the pretreatment size of the tumor. Both study groups showed similar overall survival.

Under the accelerated approval program, drugs for serious and life-threatening diseases can be made available earlier in the development process if a promising effect of the drug is observed. As part of the approval, Amgen committed to conduct a postmarketing trial to show whether the drug improves patients' survival in patients with less prior chemotherapy.