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Tarceva OK'D for Cancer of Pancreas

Posted on: Thursday, 3 November 2005, 06:00 CST

By Liz Szabo

The Food and Drug Administration approved a lung cancer medication Wednesday as a new treatment for pancreatic cancer.

Tarceva does not cure pancreatic tumors and helps patients live only a little longer, according to a study of more than 500 patients that led to the drug's approval. But while Tarceva may be only a "small step forward," it also could be a "harbinger of things to come," says Robert Wolff, an associate professor at Houston's M.D. Anderson Cancer Center who was involved in the study.

Tarceva -- a pill that causes fewer side effects than traditional chemotherapy -- belongs to a new class of cancer fighters called "targeted therapies" that aim to silence growth signals inside tumor cells. It is the first targeted therapy to prolong survival in pancreatic patients, Wolff says, and the first approved drug in years to improve on older therapies. Tarceva was first approved last year for lung cancer.

In the pancreatic cancer study, researchers found that 24% of those who combined Tarceva with standard chemotherapy were alive after one year compared with 19% who took chemo alone, according to Genentech of South San Francisco, which markets the drug. On average, patients who took Tarceva lived 6.4 months, or about 12 days longer than the other patients.

Julie Fleshman, president and chief executive officer of the Pancreatic Cancer Action Network, says she welcomes even such modest progress. "Patients with pancreatic cancer don't have a lot of options," she says.

Pancreatic cancer, the USA's fourth-leading cause of cancer death, kills more than 95% of its victims, most of them within months of diagnosis, the American Cancer Society says. It estimates that 32,180 people will be diagnosed with the disease this year and that 31,800 will die from it.

Doctors also are testing other targeted therapies, such as Erbitux and Avastin, already approved for colon cancer, in pancreatic tumors, Wolff says. He hopes that Tarceva will be the first of many sophisticated new drugs against pancreatic tumors. On Wednesday, researchers at the European Cancer Conference in Paris announced interim results from a trial of a conventional chemotherapy drug, Xeloda, which also seems to extend survival in pancreatic cancer patients.

But Wolff questions whether Tarceva's small benefits are worth its cost -- nearly $90 a day -- especially since the drug is not always covered by insurance. Tarceva also poses some risks. Two of its most common side effects are diarrhea and skin rashes, but it can cause potentially fatal lung problems, Genentech says.

Denise Swartzman, 53, a pancreatic cancer survivor from Bullhead City, Ariz., says she is thrilled by the FDA's decision. She participated in a clinical trial in 2002. Her tumor shrunk enough for doctors to remove it, and she now appears cancer-free.

(c) Copyright 2005 USA TODAY, a division of Gannett Co. Inc.

Source: USA TODAY

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