Schering-Plough Corp won a narrow vote from the Food and drug Administration (FDA) advisory panel recently to market its drug PegIntron, available in injection form, for melanoma patients undergoing surgery for skin cancer.
The panel voted 6-4 that the benefits of the drug will outweigh its toxic side effects. Panel chairman Dr. Gary Lyman, director of cancer research at Duke University Medical Center said, "This could be helpful, there are very few options for these patients".
Schering has already got the approval to treat liver disease and is now seeking FDA permission to sell the drug for use inpatients whose melanoma has spread to the lymph nodes and who undergo surgery to remove both the cancer and surrounding lymph nodes.
PegIntron is a drug which is alpha interferon protein-based which aims to help the body fight off tumors, infection and other diseases. It is a self-injection drug to be used once a week for five years.
Representatives for Schering informed the panel of FDA that the lower-dose PegIntron was less toxic and also more convenient for patients who might not otherwise opt for another intensive drug called Intron A.
Intron A has some severe side effects like heart attacks, depression, suicidal behavior, and vision complications. PegIntron patients also experienced some heart problems and depression according to FDA reviewers.
The FDA panel had a mixed opinion but most of them said that this drug will give the patients another option.
The FDA will review the panel's recommendation before making a final decision.











