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Outline
What is the generic name?
ERLOTINIB HYDROCHLORIDE
What is the Trade Name for ERLOTINIB HYDROCHLORIDE?
TARCEVA
What are the Indications for ERLOTINIB HYDROCHLORIDE?
- 1 INDICATIONS AND USAGE TARCEVA is a kinase inhibitor indicated for: • The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. ( 1.1 ) • First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. ( 1.2 ) Limitations of Use: • Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations. ( 1.1 ) • TARCEVA is not recommended for use in combination with platinum-based chemotherapy. ( 1.1 ) 1.1 Non-Small Cell Lung Cancer (NSCLC) TARCEVA ® is indicated for: • The 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 receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen [see Clinical Studies ( 14.1 , 14.3 )]. Limitations of use: • Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations [see Clinical Studies ( 14.1 , 14.2 )]. • TARCEVA is not recommended for use in combination with platinum-based chemotherapy [see Clinical Studies ( 14.4 )] . 1.2 Pancreatic Cancer 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 ( 14.5 )] .
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References: https://open.fda.gov/
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