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: ‚Ä¢ 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 ) ‚Ä¢ First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine. ( 1.2 ) Limitations of Use: ‚Ä¢ Safety and efficacy of TARCEVA have not been established in patients with NSCLC whose tumors have other EGFR mutations. ( 1.1 ) ‚Ä¢ TARCEVA is not recommended for use in combination with platinum-based chemotherapy. ( 1.1 ) 1.1 Non-Small Cell Lung Cancer (NSCLC) TARCEVA ¬Æ is indicated for: ‚Ä¢ 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: ‚Ä¢ 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 )]. ‚Ä¢ 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 )] .

References: https://open.fda.gov/