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FDA Approves New Drug for Two Cancers

Sutent works against stomach and kidney cancers

THURSDAY, Jan. 26, 2006 (HealthDay News) -- U.S. health officials on Thursday announced the approval of a drug to fight a rare type of stomach cancer as well as advanced kidney cancer.

Sutent (sunitinib), made by Pfizer Inc, is the first cancer drug to be approved for two indications simultaneously.

The approval for gastrointestinal stromal tumors (GIST) was a regular one, while the approval for kidney cancer happened in just six months on an accelerated schedule.

"I really believe this is an advance," said Dr. Richard Pazdur, director of the Office of Oncology Drug Products at the U.S. Food and Drug Administration's Center for Drug Evaluation and Research. "We're taking a look really at two situations, two diseases that are different."

About 32,000 new cases of advanced kidney cancer and 5,000 cases of GIST are diagnosed each year, according to the American Cancer Society.

Sutent is a tyrosine kinase inhibitor and works by starving tumors of blood and necessary nutrients.

The drug was approved to treat GIST patients whose cancer had advanced or who could no longer tolerate treatment with Gleevec (imatinib), a leukemia drug that also worked to fight GIST.

According to research presented last year at the American Society of Clinical Oncology and the European Cancer Conference, Sutent delayed the time it took for tumors to reappear: in patients taking Sutent, the time to tumor progression was 27 weeks, versus just six weeks for patients in the placebo arm.

GIST was virtually untreatable until Gleevec was approved. But Gleevec usually stops working after about two years, researchers noted.

"Gleevec was a major advance, but it was not curative in the vast majority of patients," Pazdur said. "Hence, people need therapeutic options when they relapse from the disease."

Sutent reduced the size of the tumor in patients with advanced renal cell carcinoma (RCC).

The development of this drug marks the end of a long period with few advances.

"There has been a dearth of active therapies," Pazdur said. "The last one approved was last month, and, before that, we're talking about a dry spell of almost a decade, when interleukin was approved for that condition."

Sutent did have side effects, including diarrhea and fatigue.

The drug is also unusual in that it targets multiple tumor activities at one time. Doctors are hopeful it will usher in a new era of combinations of finely targeted drugs that can greatly improve the prognosis of cancer patients.

"It's important for people to realize that the development of a drug really doesn't end with the approval of a drug," Pazdur said. "It just is the start of the development of a drug."

Officials are hoping to see more applications for these drugs as well as more drugs to target these two deadly cancers.

More information

For more on GIST, head to the American Cancer Society.

SOURCES: Jan. 26, 2006, news briefing with Richard Pazdur, M.D., director, Office of Oncology Drug Products, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
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