FDA Approves Use of Tarceva to Treat Pancreatic Cancer

Genentech Inc. and partner OSI Pharmaceuticals Inc. on Wednesday won U.S. approval to promote the lung cancer drug Tarceva as a treatment for pancreatic cancer.

The added use is the first for Tarceva since the Food and Drug Administration granted initial approval a year ago. Genentech, based in South San Francisco, and OSI, based in Melville, N.Y., said that 24% of people who took Tarceva with another drug lived at least a year, compared with 19% of those not given the drug.

But the median life expectancy of pancreatic cancer patients increased by just 12.8 days, prompting some cancer specialists to question whether the FDA should consider the drug effective for this use.

A panel of FDA advisors voted 10 to 3 to recommend approval of the new use for the drug at a Sept. 13 meeting. Among those in the minority was panel Chairwoman Silvana Martino, who said it was difficult to gauge whether regulators were helping terminally ill patients by postponing their deaths by a matter of days or weeks.

The FDA approval may add as much as $75 million to annual sales of Tarceva, bringing peak revenue to $700 million, Geoffrey Meacham, a J.P. Morgan Securities analyst in New York, said Monday in a report.

The average life expectancy for people whose pancreatic cancer has spread in the body is three to six months, Genentech and OSI said.

Genentech shares rose 70 cents to $91.75. OSI shares rose $1.45 to $23.73.