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New Drug Approved for Two Hard-to-Treat Cancers


Author:

Karen Barrow

Medically Reviewed On: February 08, 2006

A new drug has been approved to treat both advanced kidney cancer and a rare form of stomach cancer when other therapies fail to help.

The drug, Sutent, is the first cancer treatment to be simultaneously approved by the FDA for the use in two distinct forms of cancer. This drug was deemed so important to patients facing these diseases, the FDA gave Sutent priority review and approved it in a mere six months. It is one of the latest forms of treatment which targets specific cancer cells, as opposed to chemotherapy, which seeks out any rapidly-dividing cells.

"[This] approval is a major step forwards in making breakthrough treatments available for patients with rare and difficult-to-treat forms of cancer," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research in a press release.

Sutent, developed by Pfizer, was approved for the treatment of gastrointestinal stromal tumors (GIST), a rare form of stomach cancer that will be diagnosed in approximately 5,000 Americans this year.

While more common forms of stomach cancers begin in one type of cell in the lining of the gastrointestinal tract, it is still not entirely clear how GIST tumors form, making a successful treatment for GIST all the more elusive. However, when patients with GIST were treated with Sutent, tumor growth was slowed significantly. It took 27 weeks for tumors to progress in patients treated with Sutent, compared to six weeks in untreated patients.

At the same time, Sutent also showed promise in treating advanced kidney cancer, a disease that will be diagnosed in over 36,000 Americans this year. However, instead of slowing the growth of the tumor, as it did for GIST patients, Sutent reduced the size of tumors in the kidney. One trial showed that Sutent could reduce the size of a kidney tumor as much as 37 percent.

In both cases, Sutent is meant to be used after more traditional treatments have failed. Side effects include diarrhea, skin discoloration, mouth irritation and weakness. The drug has not yet been shown to reduce the number of deaths from these cancers, but for patients who cannot tolerate the side effects of a particular drug or whose cancer becomes unresponsive to the traditional form of therapy, Sutent may offer a good alternative.

"New therapies, such as Sutent, are helping expand options for patients for whom there are limited alternatives," said Galson.

 

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