Randy Dotinga

In November 2018, the FDA issued a draft guidance recommending metastasis-free survival as an endpoint in drug trials for nonmetastatic castration-resistant prostate cancer, suggesting a major change in expectations for treatment of this tumor type.

Long-term metastatic control is an important goal for patients with high-risk renal cell carcinoma after nephrectomy. In recent years, adjuvant therapy with tyrosine kinase inhibitors has entered the picture to potentially fill this unmet need.