The magnitude of clinical benefit and the veto of the Italian regulatory authority for renal cancer treatment

In the recent years, the systemic treatment of patients with metastatic renal cell carcinoma (mRCC) has undergone profound innovations, offering the availability of new drugs, and raising the bar of the survival expectation in this previously almost always incurable disease. The appearance of relevant rates of complete response, among the outcomes of patients treated in the last pivotal trials with drug combinations based on immune checkpoint inhibitors (ICI), finally revealed the concrete possibility of curing a meaningful percentage of mRCC patients [1]. The cornerstone of mRCC treatment, represented by VEGFR-targeted tyrosine kinase inhibition (TKI) with oral agents, has been recently...