The invention relates to antitumor agent on the base of BCG vaccine, the method his preparation and its application in patients diagnosed with oncological diseases. The agent according the invention is a mixture of two individual fractions: Fraction 1 - Live BCG bacteria and Fraction 2 - Extract-Filtrate of BCG Vaccine where the ratio between them may vary from 1:0.01 to 0.01:1. The agent is used in the treatment of all forms of cancer at all stages of the progress of the disease. The agent according the invention allows maximum opportunity for action of the BCG vaccine antitumor agent to terminate of fast and unchecked proliferation of tumor cells, reduced toxicity and blocking of the inhibitive effect of tumor cells on normal cells in the body.