FDA advisors back Schering-Plough’s PegIntron for melanoma

A US Food and Drug Administration advisory committee has voted in favour of approving Schering-Plough’s hepatitis C drug PegIntron for the treatment of skin cancer.

After considering the company’s supplemental filing for the drug, the FDA’s Oncologic Drugs Advisory Committee voted six to four in favour of issuing a full green light for the adjuvant treatment of patients with Stage III malignant melanoma - when the cancer has spread to the lymph nodes - by once-weekly self injection.

Malignant melanoma is currently the deadliest form of skin cancer and the American Cancer Society estimates that around 8,650 people will die from the disease in the US this year. Treatment options are sadly limited and its incidence is rising, highlighting the urgent need for new and effective therapies.

PegIntron pegylated (interferon alfa-2) was approved in its primary indication – hepatitis C – back in 2001, but clinical trials have also demonstrated its potential in the management of skin cancer, with patients receiving the drug experiencing a median relapse-free survival of 34.8 months compared to 25.5 months in the observational arm.

However, the drug, like others in the interferon alfa class, is associated with some pretty nasty side effects – including fatigue, elevations in blood liver function tests, depression, flu-like symptoms, and neutropenia, which caused a large number of patients to drop out of the trial and have been of some concern to regulators.