Tough Sell for Lung Cancer Drug

The drug company OSI Pharmaceuticals Inc. makes its pitch this week to expand use of its chemotherapy drug Tarceva in patients who have advanced lung cancer. It may be a tough sell.

A panel of medical experts who advise the Food and Drug Administration will listen to a presentation by the Melville, New York-based company on Wednesday. And while the FDA's staff says Tarceva works better than a placebo in studies of patients, there's a question of whether the drug works any better than other drugs.

This is always a sticking point with the FDA. While there's a great need to treat cancer patients, drug companies have to prove that their medicine works better than those already being sold. The FDA staff questions whether Tarceva works any better than other drugs, including Sanofi-Aventis SA's Taxotere.

"The main issue concerns other available treatment options for patients in this randomized trial," the FDA says in a report prepared for Wednesday's meeting.

Tarceva is OSI's most important drug, making up 85 percent of its revenue. But Tarceva revenue rose only 3 percent through the first nine months of the year, to $257.9 million, and getting the OK for a new use for the drug most certainly would boost that percentage.

Total sales of Tarceva were $1.1 billion in 2008, but OSI shares the revenue with Roche Holdings AG's Genentech, which helps sell the drug.

Besides helping the bottom line for OSI and Roche, Tarceva approval would be welcome news to patient support groups. Many advocacy groups are critical that little research is being done in the area of lung cancer, compared with other diseases.

Lung cancer remains the most deadly category of the disease, killing more Americans a year than breast, prostate, colon, liver, kidney, and skin cancers combined, according to the Lung Cancer Alliance.