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FDA Votes AGAINST Tarceva as maint. therapy for adv. stage


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(*I'm personally disappointed with this decision)

ODAC votes against erlotinib as maintenance therapy for advanced NSCLC

Yesterday, the FDA Oncologic Drugs Advisory Committee voted 12-1 against recommending the use of erlotinib as first-line maintenance monotherapy for patients with advanced non-small cell lung cancer.

The recommendation was based on findings from the phase-3 SATURN trial. SATURN was an international, placebo-controlled, double blind trial of 889 patients with advanced NSCLC. All patients received four cycles of standard first-line platinum-based chemotherapy. Researchers then randomly assigned patients erlotinib (Tarceva, OSI Pharmaceuticals; n=438) or placebo (n=451).

SATURN data were presented at the 2009 ASCO Annual Meeting in Orlando.

Median PFS, the primary endpoint, with erlotinib was 12.3 weeks vs. 11.1 weeks with placebo. The expert panel decided that these data were insufficient to approve erlotinib as first-line maintenance therapy for patients with locally advanced or metastatic NSCLC who had not progressed after platinum-based chemotherapy.

The median OS, a secondary endpoint, was 12 months with erlotinib vs. 11 months with placebo. This translated into a 19% reduction in the risk for mortality (P=.0088).

The most common adverse events with erlotinib were rash and diarrhea, according to data presented.

Ronald Richardson, MD, of the division of medical oncology at the Mayo Clinic in Rochester, Minn., was one of the panelists who voted against the therapy. “We were presented with a single study that has some design flaws showing some very modest or even minimal benefit,” he said during the meeting.

“My other concern is [that] this committee should be careful about setting precedence, particularly with the approval of drugs through single studies in which the design is an issue and benefits are marginal. We should maintain the integrity of the data at which we look,” Richardson said.

Panel member Margaret A. Tempero, MD, deputy director of the University of California at San Francisco Helen Diller Family Comprehensive Cancer Center, was the only panelist who voted in favor of the drug indication.

“Although this trial was not the one the committee members wanted to see, it was a trial that asked a reasonable question, and it was done in full consultation with the FDA and met the endpoint the sponsors expected,” she said during the meeting.

The drug company released a statement in a press release indicating it will continue to work with regulatory agencies to further explore how best to pursue the outcome of having an oral, well-tolerated treatment option that can maintain the initial benefit from cytotoxic chemotherapy for treating advanced lung cancer.


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