In the News

Jan 25, 2010

Tarceva Reprieve? FDA Delay Could Mean Little Either Way

BioWorld Insight

By Randy Osborne, Editor

Ed Kissel, VP of Analysis, IntrinsiQ shared his insight and opinions in this article.

Last week's Tarceva news – unlike the thumbs-down vote by an FDA advisory panel in December – came as little surprise: The action date for a decision on the already-marked EGRF drug in a new indication, first-line maintenance therapy for non-small-cell lung cancer, has been set back 90 days to April 18.

Many regard Tarceva (erlotinib) as ultimately doomed in that setting. A larger question is: What would the agency's refusal mean for other companies with special protocol assessments and agreed-upon endpoints that are met?

That's uncertain. But a larger question for Tarceva's developers involves whether an approval in first-line maintenance, for all the noise, even matters that much. Ed Kissel, vice president of analysis with the oncology data collector IntrinsiQ, has doubts.

"It's not going to be that big of a deal," he said. "Sales average about $125 million per quarter in the U.S., and I see it adding $25 million to $30 million per quarter. If I were management [of OSI Pharmaceuticals Inc. and Genetech Inc., not part of Roche Holding AG], I would probably look elsewhere."

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