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Lilly Gemzar for ovarian cancer

Executive Summary

A new indication for advanced ovarian cancer for Lilly's Gemzar will be reviewed by FDA's Oncologic Drugs Advisory Committee on March 15. Gemzar is already approved for pancreatic, breast and non-small cell lung cancers. The committee will also discuss preclinical requirements and Phase I trial design for oncologic products. On March 14, the committee's Pediatric Oncology Subcommittee will discuss Phase IV commitments for Novartis' Exjade (deferasirox), which received accelerated approval for treating chronic iron overload due to blood transfusions in November (1"The Pink Sheet" Nov. 7, 2005, p. 14). The committee will also consider pediatric studies of methotrexate and daunomycin and FDA's process for handling drug shortages. The meeting will be held at the Hilton in Gaithersburg, Md., beginning at 8 a.m...

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