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These highlights do not include all the information needed to use TARCEVA safely and effectively. See full prescribing information for TARCEVA. TARCEVA (erlotinib hydrochloride) tablet for oral use Initial U.S. Approval: 2004
Medication labelWhy this: Advisory · dailymed-prescription
Enter section text here TARCEVA monotherapy is indicated for the treatment of patients with locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen [see Clinical Studies (14.1)]. Results from two, multicenter, placebo-controlled, randomized, Phase 3 trials conducted in first-line patients with locally advanced or metastatic NSCLC showed no clinical benefit with the concurrent administration of TARCEVA with platinum-based chemotherapy [carboplatin and paclitaxel or gemcitabine and cisplatin] and its use is not recommended in that setting [see Clinical Studies (14.3)]. TARCEVA in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer [see Clinical Studies (14.3)].
- generic_name
- erlotinib hydrochloride
- product_names
- erlotinib hydrochloride
- ndc
- 54868-5290, 50242-062, 54868-5290-0, 54868-5474, 50242-063, 54868-5474-0, 54868-5447, 50242-064, 54868-5447-0
- group
- drugs
- license
- us-gov-pd
- attribution
- Courtesy of the National Library of Medicine
- reviewed
- 2026-09-18
- language
- en