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1. Indications And Usage Erlotinib Tablets Are 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 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 Clinical Studies (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) ] .
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