Oncologic Drugs Advisory Committee

Oncologic Drugs Advisory Committee

December 2, 2010, from 8 a.m. to 5 p.m.

Agenda: On December 2, 2010, during the morning session, the committee will discuss biologics license application (BLA) 125377, with the proposed trade name Yervoy (ipilimumab), manufactured by Bristol-Myers Squibb Company. The proposed indication (use) for this product is for the treatment of advanced melanoma in patients who have received prior therapy. During the afternoon session, the committee will discuss new drug application (NDA) 022-405, with the proposed trade name Zictifa (vandetanib) Tablets, manufactured by iPR Pharmaceuticals, Inc., represented by AstraZeneca Pharmaceuticals LP (authorized U.S. agent). The proposed indication (use) for this product is for the treatment of patients with unresectable (non-operable) locally advanced or metastatic medullary thyroid cancer.