US FDA oncology panel backs GSK's Votrient and S-P's Pegintron for new indication

The US Food and Drug Administration's Oncologic Drugs Advisory Committee has come up with positive recommendations on two cancer drugs, UK drug giant GlaxoSmithKline's Votrient (pazopanib) and a new indications for US major Schering-Plough's Pegintron (pegylated interferon alfa-2b).

The ODAC voted unanimously in support of the approval of Votrient, specifically, that the benefit-to-risk profile is acceptable for patients with advanced renal cell carcinoma. Pazopanib is an investigational, oral treatment for patients with advanced RCC.

However, GSK's studies backing the application showed higher rates of liver damage among patients taking the drug, compared with those on placebo. FDA scientists said the drug likely caused two liver-related deaths in the study. Despite those issues, panelists said the side effects were not significantly worse than similar cancer drugs. The experts added that the company should be required to submit data from ongoing studies to ensure the drug's liver toxicity does not increase over time.

Majority for Pegintron in malignant melanoma

The ODAC also recommended approval by a vote of six to four for Pegintron in the adjuvant treatment of patients with Stage III malignant melanoma. Sales of Pegintron totaled $914 million in 2008. S-P also markets Intron A, the only other FDA-approved drug for treatment of recurring skin cancer after surgery.

"Treating malignant melanoma remains a challenge given the limited treatment options that are currently available," said John Kirkwood, Director of the Melanoma Center and Professor and Chief of the Division of Medical Oncology at the University of Pittsburgh School of Medicine, Pittsburgh, USA. "Today's positive recommendation of pegylated interferon alfa-2b by the committee represents an important step toward a potential new option in the treatment of Stage III malignant melanoma, especially as the incidence of the disease continues to increase," he noted.