by Playfuls Staff |
18th July 2006
Eli Lilly and Company
announced that the United States Food and Drug
Administration (FDA) has approved GEMZAR (gemcitabine HCl) for use in the
treatment of women living with recurrent ovarian cancer. This marks the fourth
approval GEMZAR, an anti-cancer agent, has been granted by the FDA. [more]
"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.
