• First-line treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test.
• Maintenance treatment of patients with locally advanced or metastatic NSCLC whose disease has not progressed after four cycles of platinum-based first-line chemotherapy.
• Treatment of locally advanced or metastatic non-small cell lung cancer after failure of at least one prior chemotherapy regimen.
• First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

• Diagnosis of NSCLC

AND

• Patient has known active EGFR exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test

OR

• Failure or clinically significant adverse effects to platinum-based chemotherapy regimen (e.g., cisplatin, carboplatin)

• Diagnosis of locally advanced, unresectable or metastatic pancreatic cancer

AND

• Must be used in combination with gemcitabine

• Diagnosis of recurrent chordoma (form of bone cancer)

• Diagnosis of kidney cancer that has relapsed or surgically unresectable stage IV disease with non-clear cell histology

• First-line therapy for NSCLC in combination with platinum-based chemotherapy
• Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  

• National Comprehensive Cancer Network (NCCN) Practice Guidelines for NSCLC recommend platinum-based chemotherapy regimens for first-line therapy for advanced NSCLC.
• Per NCCN guidelines (category 2A), Tarceva is recommended as first line therapy in patients with advanced, recurrent, or metastatic nonsquamous NSCLC who have known active EGFR mutation or gene amplification regardless of their performance status. This recommendation is based on the results of a phase III trial in which patients with EGFR mutations who received gefitinib had increased progression free survival (25% vs. 7%), response rate (71%) and quality of life and fewer side effects when compared to those receiving chemotherapy (carboplatin/paclitaxel).
• Results from 2 placebo-controlled, randomized, phase III trials showed no clinical benefit with concurrent administration of Tarceva with platinum-based chemotherapy.
• Contraindications to platinum-based chemotherapy regimens may include pre-existing neuropathy, and other complicating comorbidities (e.g. transplant patients; patients with chronic renal insufficiency).
• NCCN Practice Guidelines do not recommend systemic, cytotoxic chemotherapy for patients of any age with a Performance Status (PS) score of 3-4 for NSCLC except Tarceva for EGFR mutation positive patients.

• Tarceva monotherapy for pancreatic cancer has not been studied.
• Colorectal, head, neck, prostate, and ovarian cancer are class III recommendations in Micromedex.
• NCCN recommends Tarceva (2A) as single agent therapy for recurrent chordoma and for relapsed or surgically unresectable stage IV kidney cancer with non-clear cell histology.

Tablets: 25 mg, 100 mg, 150 mg