ODAC Recommends Approval of Pegylated Interferon Alfa-2b for Malignant Melanoma
The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for pegylated interferon alfa-2b (PegIntron) in the adjuvant treatment of patients with stage III malignant melanoma.
The US Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval by a vote of six to four for pegylated interferon alfa-2b (PegIntron) in the adjuvant treatment of patients with stage III malignant melanoma.
Pegylated interferon alfa-2b is a longer-acting form of the protein interferon alfa-2b (Intron A). The drug is administered subcutaneously once-weekly via self-injection.
Schering-Plough filed the supplemental Biologics License Application (sBLA) for this indication to the FDA in September 2007.
![A third of patients had a response [to lifileucel], and of the patients who have a response, half of them were alive at the 4-year follow-up.](/_next/image?url=https%3A%2F%2Fcdn.sanity.io%2Fimages%2F0vv8moc6%2Fcancernetwork%2F6b7c9a3270c71a70749ba86000cfc78a29d74309-2988x1702.png%3Ffit%3Dcrop%26auto%3Dformat&w=3840&q=30 "A third of patients had a response [to lifileucel], and of the patients who have a response, half of them were alive at the 4-year follow-up.")
