Advancements in Tumor Immunotherapy, Cancer Vaccines by H. Arnouk

By H. Arnouk

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2004). The treatment is accompanied by the toxicities so severe that many patients decline to use it at all. Relatively mild and transient toxicity of Provenge compared to the chemotherapy drugs was one of the major factors that have led to its final approval by the FDA. While Provenge's approval certainly represents a significant achievement in the field of immunotherapy, the controversy surrounding its approval remains unresolved.

For the “established efficacy”, the doctor should be able to tell the patient with full confidence that this is established to be an efficacious therapy for the disease. At that time, there were no sufficient grounds for such confidence. However, there was ”substantial evidence” that the treatment may work, so the efforts should be continued to evaluate it. Several members of the committee agreed that while the data did not establish efficacy of Provenge, there was substantial evidence that the drug works.

There was no evidence of toxicity related to the vaccine. Two patients demonstrated a partial response. Forty-eight percent of the patients demonstrated an immunological response with an increase in CD4 and/or CD8+ T-cell expression. The authors concluded that this approach was feasible and tolerable. , 2007). 4. Bladder cancer Approximately 70% to 80% of patients diagnosed with bladder cancer present with superficial, noninvasive malignancies, which can often be cured. Deeply invasive 30 Advancements in Tumor Immunotherapy and Cancer Vaccines malignancies can sometimes be cured by surgery, radiation therapy, or a combination that includes chemotherapy.

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