Approved by the FDA under a 46-day priority review process, Eloxatin (oxaliplatin) injection offers an alternative treatment for patients with advanced, refractory colorectal cancer. It's intended for use in combination with an infusion of 5-fluorouracil and leucovorin (5FU/LV) in patients whose disease has recurred or worsened following therapy with a combination of bolus 5-FU/LV plus irinotecan therapy. Eloxatin is also being evaluated for its benefits as a treatment for cancer-related symptoms, such as pain, weight loss, and fatigue, and for its effect on survival rates.
The approval of Eloxatin was based on an ongoing study of the safety and efficacy of the drug, alone and in combination with 5-FU/LV. The marketing application to the FDA, submitted to "rolling review" procedures set up for fast-track applications, was approved in just 7 weeks-the fastest yet for a cancer drug. Fast-track applications are reserved for drugs in development with the potential to be an advance in treatment for a serious illness.
Intended for use by clinicians experienced in cancer treatment Eloxatin is labeled with a "black box" warning highlighting possible anaphylactic-like reactions. The drug can have a toxic effect on nerve endings that may result in either an acute or cumulative pattern of adverse reactions, such as a feeling of numbness or tingling, especially in the hands or feet or around the mouth or throat This reaction usually occurs within hours or days of dosing. Patients may have trouble performing ordinary daily tasks, such as buttoning clothes; however, these problems generally improve after completion of treatment Diarrhea, vomiting, anemia, allergic reactions, bleeding, and infection are other potential adverse reactions.
Eloxatin is a product of Sanofi-Synthelabo.
Copyright Springhouse Corporation Nov 2002
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