On November 18, 2004, OSI Pharmaceuticals, Inc. and Genentech, Inc. a ounced that the U.S. Food and Drug Administration (FDA) a roved, after priority review, Tarceva™ (erlotinib) for the treatment of patients with locally advanced or metastatic non-small cell lung cancer ( CLC) after failure of at least one prior chemotherapy regimen.

TarcevaTM is an oral tablet indicated for daily administration. Results from two multicenter, placebo-controlled, randomized Phase III trials conducted in first-line patients with locally advanced or metastatic CLC showed no clinical benefit with the concurrent administration of TarcevaTM with platinum-based chemotherapy (carboplatin and paclitaxel or gemcitabine and ci latin), and its use is not recommended in that setting. Tarceva is the only drug in the epidermal growth factor receptor (EGFR) cla to demo trate in a Phase III clinical trial an increase in survival in advanced CLC patients.

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Tarceva Safety Information There have been infrequent reports of serious interstitial lung disease (ILD), including fatalities, in patients receiving Tarceva for treatment of CLC or other advanced solid tumors. In the randomized, Phase III, single-agent study, the incidence of ILD (0.8%) was the same in both the placebo and Tarceva grou . The overall incidence of ILD in Tarceva-treated patients from all studies was a roximately 0.6 percent. There are no adequate and well-controlled studies in pregnant women using Tarceva. Women of childbearing potential should be advised to avoid pregnancy while on Tarceva (Pregnancy Category D). Asymptomatic increases in liver tra aminases have been o erved in Tarceva treated patients, periodic liver function tests should be co idered. Dose reduction or interruption of Tarceva should be co idered if changes in liver function are severe. Co-treatment with the potent CYP3A4 inhibitor ketoconazole increases erlotinib AUC by 2/3. Caution should be used when administering or taking Tarceva with ketoconazole and other strong CYP3A4 inhibitors. Pre-treatment with the CYP3A4 inducer rifampicin decreased erlotinib AUC by about 2/3. Alternate treatments lacking CYP3A4 inducing activity should be co idered. If an alternative treatment is unavailable, a Tarceva dose greater than 150mg should be co idered. If the Tarceva dose is adjusted upward, the dose will need to be reduced upon discontinuation of rifampicin or other inducers. In clinical trials, the most common adverse reactio in patients receiving Tarceva were rash and diarrhea. Grade 3/4 rash and diarrhea occurred in nine and six percent, re ectively, in Tarceva-treated patients. Rash and diarrhea each resulted in study discontinuation in one percent of Tarceva-treated patients. One and six percent of patients needed dose reduction for rash and diarrhea, re ectively. Please see full prescribing information for complete safety profile.

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Tarceva Fact Sheet

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