Eli Lilly and Company recently announced that the 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.
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.
“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.
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.