The United States Food and Drug Administration (FDA) has just approved Gemzar® (gemcitabine) for the treatment of recurrent ovarian cancer. The approved indication includes the use of Gemzar in combination with Paraplatin® (carboplatin) in patients whose cancer has returned or progressed at least six months following prior treatment.
The clinical trial that prompted the new FDA approval was conducted by researchers affiliated with the Gynecologic Cancer Intergroup (GCIG). This phase III clinical trial directly compared Gemzar plus carboplatin to carboplatin only as treatment for advanced ovarian cancer that had recurred. This trial included 356 patients who had received prior therapy with chemotherapy including either carboplatin or Platinol® (cisplatin).
- Half of the patients treated with Gemzar/carboplatin did not experience cancer progression at 8.6 months, compared to only 5.8 months for those treated with carboplatin alone.
- A complete disappearance of detectable cancer occurred in 14.6% of patients treated with Gemzar/carboplatin, compared with only 6.2% treated with carboplatin only.
- Overall anticancer response rates occurred in 47% of patients treated with Gemzar/carboplatin, compared with only 31% of patients treated with carboplatin only.
- The most common serious side effects associated with the addition of Gemzar included low levels of blood cells.
These results indicate the superiority of the addition of Gemzar to carboplatin for the treatment of advanced ovarian cancer that has recurred. This is the fourth indication for Gemzar.
Reference
Lilly. FDA Approves Lilly's Gemzar® For Ovarian Cancer Treatment. Available at: http://newsroom.lilly.com/ReleaseDetail.cfm?ReleaseID=203949. Accessed July 2006.
Related News
Further Evidence that Carboplatin and Gemzar® are Effective for Recurrent Platinum Sensitive-Ovarian Cancer (3/28/2005)
Doxil® and Gemzar® Effective for Treatment of Relapsed Ovarian Cancer (8/5/2005 )
Paraplatin® Followed by Taxotere® and Gemzar® Effective for Ovarian Cancer (6/18/2003 )
Gemzar® and Platinol® Effective in Women with Recurrent and Refractory Ovarian Cancer (1/30/2003 )
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