Eli Lilly's Gemzar approved for use with carboplatin in treatment of recurrent ovarian cancer

By Lisa Kerner

Charlotte, N.C., July 17 - Eli Lilly and Co. said the Food and Drug Administration approved Gemzar (gemcitabine HCl) for the treatment of recurrent ovarian cancer.

The FDA approval, the anti-cancer agent's fourth, specifies that Gemzar be used in combination with carboplatin.

Clinical data from a phase 3 study of 356 patients showed that patients treated with a combination of Gemzar and carboplatin experienced a significant improvement in progression-free survival (48% increase) and response rates compared to carboplatin alone (14.6% versus 6.2%).

"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," Robert Ozols of the Fox Chase Cancer Center in Philadelphia said in a company news release.

"The Gemzar combination can help us aggressively address this recurrent disease with increased clinical efficacy and generally manageable side effects."

Gemzar is approved in more than 90 countries and last year generated sales of $1.3 billion.

Eli Lilly is a research and pharmaceutical company based in Indianapolis.

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