OSI Gets Good News From FDA Panel

The panel votes to recommend the drug for approval to fight pancreatic cancer.
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A Food and Drug Administration advisory committee decided that

OSI Pharmaceuticals'

(OSIP)

cancer drug Tarceva is worth approving as a treatment for pancreatic cancer.

The FDA staff felt the drug didn't induce a clinically meaningful response in tumor shrinkage and survival in patients with pancreatic cancer,

according to documents released Monday, but the agency's oncologic drug advisory committee voted 10-3 to recommend that the drug be approved.

"A 10-3 vote is a strong endorsement," said CEO Colin Goddard in an interview. "Clearly the study was statistically significant."

He said the data showed a six-week survival improvement with Tarceva when used to fight pancreatic cancer, a disease that generally results in death six to eight months after diagnosis. Pancreatic cancer has the worst prognosis of all types of cancer, with a 99% mortality rate.

"It is a meaningful step forward," Goddard says, adding that as with all types of cancer, "we make incremental steps forward. We don't usually have revolutionary steps forward."

Tarceva is currently approved to treat nonsmall-cell lung cancer. Although the FDA doesn't have to follow its committees' recommendations, it usually does.