Abbott's Xinlay To Face Advisory Committee Review Sept. 13; Celgene's Revlimid On Agenda
This article was originally published in The Pink Sheet Daily
GlaxoSmithKline's Arranon (nelarabine) for acute lymphoblastic leukemia will also be part of the Sept. 13-14 meeting of FDA's Oncologic Drugs Advisory Committee.
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Supplemental NDA is based on a single Phase III trial of Tarceva plus Lilly's Gemzar vs. Gemzar and placebo.
The company plans to complete the NDA filing for Xinlay in metastatic prostate cancer by year-end, which is ahead of the timetable predicted after a pivotal trial failed to reach statistical significance. A Phase III trial in a second indication is likely to finish in 2005.
The Irvine, Calif., firm also plans sNDAs for a colorectal cancer claim and an oral formulation of the leucovorin relative.