|
1 Indications And Usage Erlotinib Tablets Are Kinase Inhibitors 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 Erlotinib Tablets Have Not Been Established In Patients With Nsclc Whose Tumors Have Other Egfr Mutations. (1.1) • Erlotinib Tablets Are Not Recommended For Use In Combination With Platinum-Based Chemotherapy. (1.1) 1.1 Non-Small Cell Lung Cancer (Nsclc) Erlotinib Tablets Are 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 Erlotinib Tablets Have Not Been Established In Patients With Nsclc Whose Tumors Have Other Egfr Mutations [See Clinical Studies (14.1, 14.2)] . • Erlotinib Tablets Are Not Recommended For Use In Combination With Platinum-Based Chemotherapy [See Clinicalstudies (14.4)] . 1.2 Pancreatic Cancer Erlotinib Tablets In Combination With Gemcitabine Are Indicated For The First-Line Treatment Of Patients With Locally Advanced, Unresectable Or Metastatic Pancreatic Cancer [See Clinical Studies (14.5)] .
|