FDA Approves New Cancer Drug
A new drug that combats both a rare stomach cancer and advanced kidney cancer won speedy federal approval Thursday.
Sunitinib, to be marketed by Pfizer Inc. as Sutent, is the first cancer drug to simultaneously win Food and Drug Administration approval for two conditions, the agency said.
The FDA granted the medication priority review as a kidney cancer drug and approved it just six months later, given its usefulness in treating the serious and life-threatening disease.
A trial of Sutent as a stomach cancer treatment was cut short after the drug's ability to delay tumor growth prompted researchers to give the Pfizer drug to patients who had been taking placebos, or dummy medication.
Sutent works by depriving tumor cells of the blood and nutrients needed to grow.
The once-a-day capsule is meant to treat both gastrointestinal stromal tumors, a rare stomach cancer also known as GIST, and advanced kidney cancer. Pfizer is studying the drug for use in treating other cancers, including colorectal, breast and lung cancer.
The approval comes a month after the FDA gave its OK to sorafenib tosylate, or Nexavar, the first new drug for kidney cancer patients approved in a decade. That drug was developed by Bayer and Onyx Pharmaceuticals.
"It's obvious in renal cell carcinoma, there have been a dearth of active therapies available," said Dr. Richard Pazdur, director of FDA's Office of Oncology Drug Products. Other therapies include interferon and interleukin-2.
Dr. Charles Baum, Pfizer's global clinical leader for Sutent, said the drug's effect is "many folds greater than what's been the case with previous treatments."
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.
The FDA said Sutent should be used by GIST patients whose disease has progressed or who are unable to tolerate Gleevec, a Novartis drug currently used to treat the cancer. Studies show the drug slows the growth of tumors in those patients.
In patients with advanced renal cell carcinoma - the most common type of kidney cancer - clinical trials showed Sutent reduced the size of tumors.
The FDA says it worked with Pfizer to make the drug more widely available even before approving it. More than 1,700 patients are being treated with the drug, according to the agency.
Side effects include diarrhea, skin discoloration, mouth irritation, weakness and altered taste. Also, hyperthyroidism affected 4 percent of patients in trials.