FDA ADVISERS TO EXAMINE LILLY, NOVARTIS CANCER DRUGS

The FDA's oncology drug advisers will discuss a proposed indication for Eli Lilly's Gemzar and Phase IV requirements for Norvartis' Exjade at meetings scheduled for March.

The March 13 meeting of the agency's Oncologic Drugs Advisory Committee will take up Lilly's proposed indication for Gemzar (gemcitabine HCl) for injection in combination with carboplatin for the treatment of advanced ovarian cancer that has relapsed at least six months after completion of platinum-based therapy. The committee will also discuss preclinical requirements and Phase I trial design issues for the development of oncologic products.

The FDA in May 2004 approved Lilly's supplemental new drug application for Gemzar in combination with Taxol (paclitaxel) for the treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.

The March 14 meeting of the Pediatric Oncology Subcommittee will discuss Phase IV requirements for Novarti's Exjade (deferasirox). The FDA in November 2005 approved Exjade to treat chronic iron overload in patients ages two and older. The committee also is scheduled to discuss clinical studies of methotrexate and daunomycin to be conducted under the Best Pharmaceuticals for Children Act, as well as the FDA's process for handling drug shortages.

For more information, go to http://www.fda.gov/oc/advisory/accalendar/2006/cder12542d031506.html (http://www.fda.gov/oc/advisory/accalendar/2006/cder12542d031506.html).