FDA Approval of Prostate Cancer Treatments

摘要: The United States Food and Drug Administration has approved more than ten drugs for the treatment of prostate cancer, which include hormonal, supportive, cytotoxic agents. Although these have remarkably improved management patients with disease, new treatments are greatly needed achieving better clinical outcomes. Regulatory evaluation newer agents under development is highly challenging, especially intended advanced metastatic disease resistant to castration and/or docetaxel. Substantial evidence efficacy safety must be demonstrated an agent receive marketing approval. based on adequate, well-designed, well-conducted trials that provide quantitative assessments measured benefits risks agent. improvements in survival patient-reported outcomes continue valid endpoints approving claims or agents, effective surrogates can reliably measure predict benefit remain established accelerating drug disease. Furthermore, appropriate utilization trial results very important. Subgroup analysis post-hoc not acceptable regulatory action general. Productive collaboration between all stakeholders agency one keys successful cancer treatments.