PHARMACEUTICAL NEWS

• Oral TKI Achieves Dramatic Reduction in Risk
  of GIST Recurrence
  On August 27, 2008 the United States FDA granted priority review status to Novartis’ imatinib mesylate (Glivec®), an oral tyrosine kinase inhibitor (TKI), as the first therapy for adjuvant use after surgery in KIT-positive gastrointestinal stromal tumors (GIST). Similar regulatory submissions have been filed by EMEA and other countries as well. The filings are based on clinical data from an international phase III randomized trial of 708 GIST patients who had complete surgical resection of their disease and then immediately began treatment with either imatinib 400 mg daily or placebo daily for one year. The primary endpoint was recurrence-free survival (RFS). Results: 98% of patients receiving imatinib remained recurrence-free at one year following surgery compared to 82% of those receiving placebo. This represents an unprecedented 89% reduction in risk of KIT-positive recurrence after surgery in patients treated with imatinib compared to placebo. A decision for final approval is expected within 6 months.
  
  Food for thought: With the adjuvant imatinib for GIST era about to begin, the question of treatment duration will become a hot topic. This trial addressed one year of therapy with trials of 2 years and 3 years ongoing now, but optimal duration is currently unclear.
  
  

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