On Jul. 17, 2006, Eli Lilly and Company’s Gemzar was approved by the U.S. Food and Drug Administration (FDA) for use in the treatment of women living with recurrent ovarian cancer. This marked the fourth approval by the FDA for this anti-cancer agent.

The FDA approval specifies that GEMZAR be used in combination with carboplatin, a widely-used agent, for women with advanced ovarian cancer that has relapsed at least six months after initial therapy. Clinical data submitted to the FDA showed that patients treated with a combination of GEMZAR and carboplatin experienced a significant improvement in progression-free survival and response rates compared to carboplatin alone.

GEMZAR, which is celebrating its tenth anniversary in the U.S., is approved in more than 90 countries and last year generated sales of $1.3 billion, making it Lilly’s second best-selling drug. Progression-free survival, the amount of time a woman lives before her disease recurs or worsens, is particularly important in ovarian cancer.

Ovarian cancer, which is the eighth most common cancer among women, recurs in approximately 90 percent of those who are diagnosed and treated for the first time. According to the American Cancer Society, there will be an estimated 20,180 new cases of ovarian cancer in America in 2006.

Results showed a median progression-free survival increase of 48 percent — a finding that was statistically significant — in the GEMZAR and carboplatin arm compared to the carboplatin arm (8.6 months vs. 5.8 months, p=.0038). The GEMZAR combination demonstrated a two-fold increase in complete response rate — disappearance of tumor — over carboplatin alone (14.6 percent vs. 6.2 percent, respectively). Overall response rate for the GEMZAR combination was significantly higher than carboplatin alone, with 47 percent and 31 percent of the patients responding respectively (p=.0016).