The present invention relates to a pharmaceutical composition for the treatment of tumor diseases, wherein the pharmaceutical composition contains N-[4-(1-cyanocyclopentyl)phenyl]-2-(4-pyridylmethyl)amino-3-pyridinecarboxamide or its pharmaceutically acceptable salts and erlotinib or its pharmaceutically acceptable salts, N-[4-(1-cyanocyclopentyl)phenyl]-2-(4-pyridylmethyl)amino-3-pyridinecarboxamide or its pharmaceutically acceptable salts and gefitinib or its pharmaceutically acceptable salts, preparation method thereof and a method of treating tumor diseases with the composition.本發明公開了一種治療腫瘤疾病的醫藥組成物,其是含有N-[4-(1-氰基環戊基)苯基]-2-(4-吡啶甲基)胺基-3-吡啶甲醯胺或其藥學上可接受的鹽和厄洛替尼或其藥學上可接受的鹽,或含有N-[4-(1-氰基環戊基)苯基]-2-(4-吡啶甲基)胺基-3-吡啶甲醯胺或其藥學上可接受的鹽和吉非替尼或其藥學上可接受的鹽的固定劑量組合的醫藥組成物,製備該醫藥組成物的方法和該醫藥組成物在製備治療腫瘤疾病的藥物中的用途。