The FDA has approved Gemzar for the treatment of recurrent ovarian cancer ignoring the advice of the FDA panel.
It said that Gemzar in combination with carboplatin (chemotherapy) is very effective for women with advanced ovarian cancer. The drug Gemzar also known by its generic name gemcitabine and was approved after the company provided with additional information to the FDA. According to the statistics of the American Cancer Society about 22,000 women are diagnosed with the disease and 16,000 women die each year. The problem with ovarian cancer is that the tumor tends to recur, making the treatment difficult and resulting in low survival rates.
Gemzar is already approved in the US for lung, pancreatic and breast cancers. In the clinical trails it was found that ovarian cancer patients taking Gemzar with carboplatin had increased progression-free survival rates than patients taking carboplatin alone. The FDA advisory panel voted against recommending the drug when the panel members were concerned that patients in the trial did not survive longer than those taking carboplatin alone. But the company replied that their aim is to prevent the cancer from worsening and not to help patients live longer. The treatment with Gemzar costs about $12,600 which does not increase the longevity of the patient but allows them to have less frequent chemotherapy.