FDA gives the green light for Gemzar to treat recurrent ovarian cancer

Jul 18 2006

Drug company Eli Lilly has been given approval by the U.S. Food and Drug Administration (FDA) for its drug Gemzar to be used by women living with recurrent ovarian cancer.

The approval has been granted despite the advice of an FDA panel in March that had strongly recommended against approval and questioned Lilly's trial data and the way the clinical study was conducted.

The approval has been given for Gemzar to be used in combination with carboplatin, a widely used chemotherapy, for women with advanced ovarian cancer that has relapsed at least six months after initial therapy.

According to the American Cancer Society about 22,000 American women are diagnosed with the disease each year and about 16,000 die from it.

Low survival rates are attributed to the fact that in most women, tumours tend to recur, making treatment difficult.

Ovarian cancer has one of the highest recurrence rates of all women's cancers, and when it does progress, it is frequently accompanied by significant symptoms that impinge on lifestyle.

It is the eighth most common cancer among women, and recurs in approximately 90 percent of those who are diagnosed and treated for the first time.

This is the fourth approval granted for the anti-cancer agent Gemzar. It already has approval in the United States to treat lung, pancreatic and breast cancers and is approved outside the United States for ovarian cancer, and is Lilly's second best selling product.

Many ovarian cancer patients will receive additional treatments each time their disease recurs.

According to Lilly a late-stage trial in ovarian cancer patients taking Gemzar along with carboplatin had significantly longer progression-free survival than patients taking carboplatin alone.

Progression-free survival measures the amount of time before the disease recurs or worsens.

The FDA advisory panel members were concerned that patients in the late-stage clinical trial failed to survive longer than those taking carboplatin alone.

Lilly said the main goal of the trial was to demonstrate that Gemzar could prevent the cancer from worsening and although women with recurrent ovarian cancer do not live longer on Gemzar, the drug allows them longer periods without being treated again with chemotherapy.

The FDA usually follows the advice of its advisory panels, but apparently the approval was granted after the company provided the agency with additional information.

The FDA says the new data showed that patient improvement in progression free survival "was clinically meaningful and represents clinical benefit".

The FDA has recently approved several other cancer drugs on that basis but this is the first drug approved by the FDA for ovarian cancer based upon progression-free survival, rather than an outright survival benefit.

According to the American Cancer Society, there will be an estimated 20,180 new cases of ovarian cancer in America in 2006.