ARTICLE | Product Development

Treatment finding left to the docs

September 19, 2005 7:00 AM UTC

Given the lack of good drugs for pancreatic cancer, FDA's Oncologic Drugs Advisory Committee last week voted that Tarceva should be approved for the indication despite showing a marginal clinical effect. Optimal dosing can be worked out in a post-approval setting, the panel said, advice FDA officials seem prepared to accept.

While many ODAC members agreed Tarceva erlotinib from OSI Pharmaceuticals Inc. provided only a marginal improvement in treating pancreatic cancer, 10 of the 13 voters were willing to give patients another option in a disease that has only one approved drug - gemcitabine - and a near 100% mortality rate after one year...