A Food and Drug Administration panel Wednesday rejected earlier use of the cancer drug Tarceva in patients with advanced lung cancer.

Tarceva, co-marketed by OSI Pharmaceuticals Inc. (OSIP) and Roche's (ROG.VX) Genentech unit, is currently approved to treat non-small cell lung cancer after treatment with chemotherapy failed to stop the spread of the disease. The drug is considered a second-line therapy.

The companies are seeking FDA approval to use the drug immediately after chemotherapy as a maintenance treatment in patients whose disease remained stable after chemotherapy.

However, the panel of outside medical experts voted 1 to 12 against a question that asked if Tarceva should be approved for the proposed indication as a first-line maintenance treatment. Tarceva is an oral drug that blocks an enzyme involved with cancer growth.

The companies conducted a study involving 889 patients with advanced lung cancer who had completed four cycles of chemotherapy without their disease progressing or getting worse. Half of the patients were given Tarceva while the other half were given a placebo or fake treatment. The study showed patients receiving Tarceva had a median progression-free survival of 12.3 weeks, or the time before the disease started getting worse, compared with 11.1 weeks for those on placebo.

The panel said the benefit of using Tarceva earlier in treatment than currently called for was modest and that it wasn't clear whether using the drug earlier was better than using the product once lung cancer has started getting worse.

In a background document prepared for Wednesday's meeting, the FDA said the study was successful at meeting its main goal. However, the agency said the main issue for discussion during the panel meeting is "other available treatment options."

The FDA said Tarceva, and another drug, Cocetaxel, have a median survival of three months compared to placebo when given to patients after chemotherapy has failed. Docetaxel is sold as Taxotere by Sanofi Aventis SA (SNY).

"This raises the question whether treatment with single agent erlotinib (Tarceva) or docetaxel after progression are better options than treatment with erlotinib as maintenance," the FDA said.

OSI said Tarceva provides "an important new therapeutic option" when given immediately after chemotherapy.

-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294; jennifer.corbett@dowjones.com
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