[I give DJ credit for citing the Tarceva benefit in the survival rate at one year (31% on Tarceva+Gemzar vs 22% on Gemzar alone), which is much more clinically meaningful than the minuscule gain in *median* survival of the combo arm relative to the mono arm. It is largely because of this advantage in the one-year survival rate that I think Tarceva will get a (perhaps weak) thumbs-up when all is said and done.]
By JENNIFER CORBETT DOOREN DOW JONES NEWSWIRES September 13, 2005
The Food and Drug Administration said that the small increase in overall survival from using the drug Tarceva to treat pancreatic cancer may not outweigh its risks.
OSI Pharmaceuticals Inc. is seeking FDA approval for Tarceva to treat patients with advanced pancreatic cancer and for those who can't have the cancer surgically removed [i.e. metastatic or locally-advanced cancer] in combination with Gemzar, a drug developed by Eli Lilly & Co.
An outside panel of medical experts will review Tarceva today [Tues.] and will make recommendations about whether the FDA should approve the drug. The FDA typically follows its panel's advice but it isn't required to.
Tarceva was given full approval by the FDA to treat lung cancer in the fall. The drug is marketed in the U.S. by OSI and Genentech Inc. and outside of the U.S. by Roche Holdings AG, which holds a majority stake in Genentech.
The FDA said that, based on its analysis of clinical studies involving Tarceva, patients receiving Tarceva and Gemzar had an overall survival of 12.8 days longer than those receiving Gemzar alone, which, the FDA said "raises the question whether the difference is clinically important." The studies involved 569 patients.
The agency said there was a "significant increase in toxicity" and other side effects including a sixfold increase in the number of strokes among patients receiving Tarceva. The FDA said the benefits of Tarceva "may not outweigh the risks associated with this therapy."
In its briefing document prepared for today's meeting, OSI said more patients in the Tarceva groups were alive at the one-year mark than those in the Gemzar-only group. At one year, 31.2% of Tarceva patients were alive, compared with 21.5% of the Gemzar-only patients.
OSI noted that pancreatic cancer has the highest mortality rate of any type of cancer. Once it has spread to the bone only 1.8% of patients live more than five years. About 32,000 cases of pancreatic cancer are diagnosed annually in the U.S. <<
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