Food and Drug Administration

Oncologic Drugs Advisory Committee

May 3, 2004

Briefing Information

Genasense™ (oblimersen sodium) Injection Proposed Indication for Use in Combination With DTIC Dome® (dacarbazine), Bayer Pharmaceuticals Corp., Proposed for the Treatment of Patients With Advanced Malignant Melanoma, Genta, Inc. (HTM) (PDF) (Word)

Briefing Material: May 3. 2004 AM Session - Genasense, FDA (HTM) (PDF)

Genasense Errata, FDA (HTM) (PDF) (Word)

Efaproxiral (RSR13) as an Adjunct to Whole Brain Radiation Therapy for the Treatment of Brain Metastases Originating From Breast Cancer, Allos Therapeutics, Inc. (HTM) (PDF) (Word)

Briefing Material: May 3, 2004 PM Session - RSR-13, FDA

Table of Contents (HTM) (PDF) (Word)

Clinical Review (HTM) (PDF) (Word)

Statistical Review and Evaluation - Clinical Studies (HTM) (PDF) (Word)

RSR-13 Dosing Guidelines (HTM) (PDF) (Word)