FDA Approves Vectibix for Colorectal Cancer

Vectibix, a drug meant for treating patients with advanced colorectal cancer has been approved for use in cases where the cancer has spread to other parts of the body.

Vectibix, a drug meant for treating patients with advanced colorectal cancer has been approved for use in cases where the cancer has spread to other parts of the body.Panitumamab, which is being marketed as Vectibix by Amgen Inc has been found to shrink tumor size and retard cancer cell growth.

The approval has added to the available choices of treatment for a disease, which has a high mortality rate. Colorectal cancer has been found to be the third leading cause of cancer related deaths in the United States, as much as 55,000 deaths being forecast from 150,000 new cases. The Epidermal Growth Factor Receptor (EGFR) has been found in 70% of the cancers and Vectibix acts by targeting it.

The approval was granted after conducting a randomized and controlled clinical trial on 463 patients.The cancer had spread to other parts of the body and did not respond to conventionally used drugs like Oxaliplatin, Irinotecan and Fluoropyridine. It was found that patients on Vectibix had a favorable disease progression or death rate when compared to the best standard treatment. However the FDA says that though 8% of the cases had 50% tumor shrinkage, the survival rates of both sets remains similar.

The FDA has said that the side effects of Vectibix include pulmonary fibrosis, severe skin rash and infections, gastrointestinal symptoms and infusion reactions.

Amgen's vice president and general manager Oncology Cynthia Schwalm said that Vectibix would be available from mid October for treatment of metastatic colon cancer. She said that a typical two month course of the drug will cost $16,000.It will be directly competing with Erbitux which is marketed by ImClone Systems and is approved for other cancers also.

Vectibix causes less allergic reactions when compared to Ertibux and also costs 20% less.

Amgen is bound to conduct trials wherein the drug is given to patients at an earlier stage and the survival rate is assessed, the FDA said.

Analysts predict that this will be a marketing battle, which will see more doctors using panitumamab, thanks to Amgen's dynamic sales force. Annual sales in the range of $500 million to $2 billion could be in the offing.

Source-Medindia
SRM