In Brief: Janssen Rivizor

Executive Summary

Janssen Rivizor: Oncologic Drugs Advisory Committee will discuss Janssen's vorozole NDA (20-817) for treatment of advanced breast cancer in post-menopausal women with disease progression following anti-estrogen therapy on the morning of Sept. 18. In the afternoon, the committee will review Sanofi's Photofrin (porfimer sodium) sNDA (20-451) for two indications: reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial non small-cell lung cancer, and use against endobronchial carcinoma in situ or microinvasive NSCLC in patients for whom surgery or radiotherapy are not indicated. The advisory committee will begin at 8 a.m. at the Bethesda, Md. Holiday Inn...