Washington Editor

Shares in OSI Pharmaceuticals Inc. fell to a 52-week low, $30.74, in advance of an FDA panel hearing on Tarceva (erlotinib) as the agency released a briefing document questioning the product's benefit for pancreatic cancer patients in light of its risks.

The FDA's investigators criticized data on which the drug's supplemental new drug application is based; Tarceva was approved about a year ago for non-small-cell lung cancer. Today, the agency's Oncologic Drugs Advisory Committee is scheduled to evaluate the latest application, which seeks approval for 100 mg of Tarceva plus gemcitabine as a first-line treatment in patients with locally advanced, unresectable or metastatic pancreatic cancer.

OSI's shares (NASDAQ:OSIP) were down $1.56 on volume that was more than three times its average. The stock's 52-week high reached $74.95 in December.

The FDA said that though some analyses of the single study submitted for approval showed statistically significant differences between the Tarceva/gemcitabine and placebo/gemcitabine arms, "no clinically meaningful differences in response rate, duration of response, [progression-free survival] or overall survival were observed." The agency's investigators noted that "the very small increase" in median overall survival (12.8 days) and median progression-free survival (11 days) raises a question of whether "the difference is clinically important."

In contrast, Melville, N.Y.-based OSI has presented data that shows a statistically significant, 23.5 percent improvement in overall survival in Tarceva/gemcitabine patients compared to those in the placebo/gemcitabine group. (See BioWorld Today, Sept. 21, 2004.)

Representatives from the company could not be reached for comment, though in its own documents released on the eve of the panel hearing, OSI pointed to sobering statistics about pancreatic cancer: 32,180 new cases will be diagnosed in the U.S. this year, and about 31,800 people will die from it.

Still, the FDA evaluation outlined the agency's doubts about the EGFR inhibitor's use in such a setting. Its investigators found some patients included in the company's analysis ineligible, and also noted that a re-analysis absent those patients would lead to a different result. Such data will be presented at today's meeting.

Also, the agency charged the company with failing to capture the full extent of adverse events because it did not record hospitalizations, and pointed to concerns over side effects that include stroke, cardiac ischemia/infarction, stent occlusion, infections, ILD-like events and gastrointestinal bleeding.

Lastly, the FDA criticized the lack of a second, supportive trial for the Tarceva/gemcitabine combination in pancreatic cancer patients. All such issues led the FDA to conclude that "the benefit with erlotinib/gemcitabine combination in the treatment of advanced or metastatic pancreatic carcinoma may not outweigh the risks associated with this therapy."

The drug's supplemental new drug application was filed at the end of April. It is partnered with South San Francisco-based Genentech Inc., which Monday saw its stock (NYSE:DNA) dip 96 cents to $91.40.

Recently, the company revealed plans to buy Eyetech Pharmaceuticals Inc. in a $935 million deal. (See BioWorld Today, Aug. 23, 2005.)