FDA panels set to review ipilimumab, vandetanib, and sNDA for Avodart for prostate cancer risk reduction
This article was originally published in Scrip
Executive Summary
The US FDA has called on its oncologic drugs advisory committee to review, on 2 December, Bristol-Myers Squibb's novel immunotherapy ipilimumab, to treat advanced melanoma in patients who have received prior therapy, and AstraZeneca's drug candidate, Zictifa (vandetanib), an oral multi-targeted kinase inhibitor, to treat patients with unresectable (nonoperable) locally advanced or metastatic medullary thyroid cancer. The day before, the panel will discuss a supplemental NDA (sNDA) for GlaxoSmithKline's Avodart (dutasteride) for the reduction in the risk of prostate cancer in men at increased risk of developing the disease; Merck & Co's Proscar (finasteride) will also be considered.