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FDA Approves Drug, Gemzar, for Advanced Ovarian Cancer

The U.S. Food and Drug Administration recently approved the drug Gemzar (generic name, gemcitabine) for use in women whose ovarian cancer has returned after treatment. The drug is approved to be given in combination with another chemotherapy drug, carboplatin. Gemzar is already FDA-approved for treating non-small cell lung cancer, pancreatic cancer, and metastatic breast cancer. However, it has serious side effects, such low blood cell counts, which can put women at risk for infections and bleeding. Women eligible for treating with Gemzar should discuss the advantages and disadvantages of the drug with their cancer treatment team.

According to Eli Lilly and Company, who manufacturers Gemzar, the drug is approved to be given with carboplatin for the treatment of women whose ovarian cancer has come back at least 6 months after they have been treated with a platinum-based chemotherapy. It is typically administered once a week for 2 weeks in a row, followed by 1 week without treatment. Patients receiving Gemzar with another chemotherapy drug will usually receive both drugs during the first week. This 21-day treatment cycle may be repeated, depending on the patient's medical situation.

The FDA approved Gemzar after reviewing clinical trial results of 356 women with advanced ovarian cancer who were not responding to current treatments. According to Eli Lilly and Company:

  • The women who were given the combination of Gemzar with carboplatin had almost 3 months longer from the time they started therapy until their tumor came back than the women who were given just carboplatin alone (8.6 months versus 5.8 months).
  • About 47% of the women who received Gemzar with carboplatin had their tumors shrink as compared to about 31% of the women who received carboplatin alone.

However, the American Cancer Society notes that while Gemzar helped shrink the size of their tumors, it did not increase the women's overall survival time. Moreover, Gemzar is associated with some severe side effects which caused the FDA to not approve the drug earlier this year, before new clinical trial data was provided.

According to Eli Lilly and Company, about 1 in every 10 women in the clinical trial had to have their dose of Gemzar decreased or stopped taking the drug due to side effects. The most common side effect associated with Gemzar is a low blood cell count. Low white blood cell counts put patients at risk for infections while low red blood cell counts make patients feel tired or dizzy. Low platelet counts put patients at risk for bleeding. Blood tests are performed to monitor a patient's blood cell count. Other possible side effects include mild nausea, temporary hair loss, neuropathy (numbing of fingers), fatigue, vomiting, and constipation. Many of these side effects are common with several forms of chemotherapy.

The American Cancer Society estimates that approximately 20,000 women in the United States will be diagnosed with ovarian cancer in 2006, and about 15,000 will die from the disease this year. Ovarian cancer is often called the silent killer because its symptoms can be subtle, leading to a delayed diagnosis and poorer outcome. However, if ovarian cancer is detected early, the five-year survival rate is approximately 95%.

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