Lilly Gemzar review
Executive Summary
Date for FDA Oncologic Drugs Advisory Committee review of Lilly's Gemzar for advanced ovarian cancer has been changed to March 13. The meeting had been originally scheduled for two days later (1"The Pink Sheet" Jan. 9, 2006, In Brief). The committee is also set to discuss preclinical requirements and Phase I trial design for oncologic products. Meeting date for the committee's Pediatric Oncologic Subcommittee's discussion of Phase IV commitments for Novartis's Exjade (deferasirox) and other topics is still set for March 14. [Editor's note: To 2watch a webcastor order a video/DVD of this meeting, visit FDAAdvisoryCommittee.com.]...
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Lilly Gemzar for ovarian cancer
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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