This marks the fourth approval Gemzar, an anti-cancer agent, has been granted by the FDA.
"Ovarian cancer is a devastating disease and we're honored that Lilly's research and innovation have brought about a clinical advance for women living with this disease," said Richard Gaynor, M.D., vice president of cancer research and global oncology platform leader at Lilly.
"Ovarian cancer is marked by one of the highest recurrence rates of all women's cancers, and when it does progress, it is frequently accompanied by significant symptoms that impede daily activities," said Robert Ozols, M.D., Ph.D. of the Fox Chase Cancer Center in Philadelphia. "The Gemzar combination can help us aggressively address this recurrent disease with increased clinical efficacy and generally manageable side effects."
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. 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(1), 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.
"The Gemzar and carboplatin combination offers one of the most active treatment regimens available for a platinum-sensitive disease with less risk of having neurotoxicity and significant alopecia, making this a valuable treatment option for the treatment of recurrent platinum-sensitive ovarian cancer," said Tate Thigpen, M.D., professor of medicine and director of oncology at the University of Mississippi School of Medicine.
Gaynor added that Lilly Oncology sees the Gemzar approval as a first step in ovarian cancer for the Lilly Oncology franchise. Lilly is committed to using the latest technologies and medicines to help women living with ovarian cancer. Lilly Oncology is currently evaluating other potential treatments for refractory ovarian cancer that are in earlier stages of development.
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.