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1. Indications And Usage Erlotinib Tablet 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, Unrespectable 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 Was 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 Have Not Been Established In Patients With Nsclc Whose Tumors Have Other Egfr Mutations [See Clinical Studies (14.1, 14.2)] . Erlotinib Tablet Is Not Recommended For Use In Combination With Platinum-Based Chemotherapy [See Clinical Studies (14.4)] . 1.2 Pancreatic Cancer Erlotinib Tablet 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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