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First-line efficacy

Tarceva first-line for EGFR Mut+ NSCLC

Tarceva has been proven to extend progression-free survival (PFS) in both Caucasian and Asian populations.1,2


  • The first phase III trial in Caucasians with EGFR Mut+ NSCLC
  • Tarceva median PFS was nearly double that of first-line chemotherapy



  • Over 1 year PFS in Asian with EGFR Mut+ NSCLC
  • Tarceva median PFS was nearly triple that of first-line chemotherapy


Post-platinum efficacy

Tarceva post-platinum in advanced NSCLC

Tarceva has demonstrated comparable efficacy to chemotherary (Phase III TITAN study)5

Overall survival in ITT population


Tarceva is the only second-line therapy proven to significantly improve Quality of Life (QoL) versus placebo (Phase III BR.21 study)6

Quality of life (QoL) of Tarceva vs. Placebo in 2L NSCLC


The efficacy of Tarceva is regardless of histology (Phase III TITAN study)5

Overall survival: Subgroup analysis according to history


or EGFR mutation status:
Tarceva is efficacious in both EGFR Mut+ and wild-type NSCLC (Phase III TITAN study)5

Overall survival in patietnts with EGFR wild-type



  1. Tarceva® (erlotinib) Summary of Product Characteristics, F. Hoffmann-La Roche Ltd., 2011
  2. Rosell R, et al. Erlotinib versus chemotherapy (CT) in advanced non-small cell lung cancer (NSCLC) patients (p) with epidermal growth factor receptor (EGFR) mutations: interim results of the European erlotinib versus chemotherapy (EURTAC) phase III randomized trial. The Lancet Oncology - 1 March 2012 ( Vol. 13, Issue 3, Pages 239-246 )
  3. Zhou C, Wu Y-L, Chen G, et al. Erlotinib versus chemotherapy as first-line treatment for patients with advanced EGFR mutation-positive non-small-cell lung cancer (OPTIMAL, CTONG-0802): a multicentre, open-label, randomised, phase 3 study. [published online ahead of print July 22, 2011.] Lancet Oncol. doi:10.1016/S1470-2045(11)70184-X.
  4. Zhou C, Wu Y-L, Chen G, et al. Updated efficacy and quality of life (QoL) analyses in OPTIMAL, a phase III, randomized, open-label study of first-line erlotinib versus gemcitabine/carboplatin in patients with EGFR activating-mutation positive (EGFR Act Mut+) advanced non-small-cell lung cancer (NSCLC). J Clin Oncol. 2011;29:Abstract 7520.
  5. Ciuleanu T, et al. Efficacy and safety of erlotinib versus chemotherapy in second-line treatment of patients with advanced, non-small-cell lung cancer with poor prognosis (TITAN): a randomised multicentre, open-label, phase 3 study. The Lancet Oncology - 1 March 2012 ( Vol. 13, Issue 3, Pages 300-308 )
  6. Shepherd FA, Rodrigues PJ, Ciuleanu T, et al. Erlotinib in previously treated non-small cell lung cancer. N Engl J Med 2005; 353(2): 123–32.


The EU product label for Tarceva is available in different languages.

Mechanism of action

Mechanism of Action

Click to access and download the new Tarceva mechanism of action video.

New indication for Tarceva

Tarceva is now approved for first-line therapy of EGFR Mut+ NSCLC.

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