FDA panel recommends two drugs for rare form of pancreatic cancer

Two drugs used against kidney cancer won the endorsement of a federal advisory panel Tuesday to treat a form of pancreatic cancer that strikes several hundred Americans each year.

The panel found that the benefits of Novartis Pharmaceuticals' Afinitor and Pfizer's Sutent outweighed their toxic side effects, increasing the likelihood that the Food and Drug Administration would approve their use for pancreatic neuroendocrine tumors.

The drugs provide significant new treatment options with the potential to extend the lives of patients diagnosed with the tumors.

Although the FDA is not required to follow the recommendations of its advisory panels, it often does.

Neuroendocrine tumors, which are diagnosed in about 600 Americans annually, or just over 1% of new cases of pancreatic cancer, are considerably less deadly than the more common adenocarcinomas of the pancreas. But beyond chemotherapy, which has limited effectiveness, there are few treatments if neuroendocrine tumors recur.

Apple Chief Executive Steve Jobs was diagnosed with pancreatic neuroendocrine tumors in 2003. Since then, he has taken three medical leaves, including one that began in mid-January.

Patients taking Afinitor, which was endorsed by the panel on a 10-0 vote, showed no progression of their tumors for a median of 11 months, compared with 4.6 months for patients taking a sugar pill, according to a research review by the FDA's Oncologic Drugs Advisory Committee.

The drug's side effects include mouth sores, lung inflammation and kidney failure.

There was a bit more uncertainty regarding Sutent, reflected in the 8-2 vote that the drug's benefits surpassed its drawbacks. Although Sutent also showed promise in stalling tumor growth, the data showed that its benefit was smaller and of shorter duration than Afinitor's.

In addition, some panelists worried about Sutent's side effects, which can include heart and kidney failure.

The additional time gained against tumor growth "doesn't seem like much, but to me it's like a breakthrough," said Sang-Hoon Ahn, an oncologist at Hollywood Presbyterian Medical Center in Los Angeles, where people with neuroendocrine tumors make up about 10% of the pancreatic cancer patients.

A Novartis spokeswoman said the company expected the FDA to make a decision on Afinitor by the end of June.  She said it was too early to discuss pricing for the drug as a pancreatic cancer treatment. But she said Novartis' list price to wholesalers before rebates or discounts for kidney cancer treatment is between $5,500 and $6,200 for a 28-day supply.

A Pfizer spokeswoman said FDA action on Sutent was expected by the end of the year.

FDA approval of the drugs for pancreatic cancer would mean they would eventually be evaluated for effectiveness against similar tumors in other organs. Neuroendocrine tumors can strike other parts of the body, including the lungs and intestines.


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