The approval is the first by the FDA for an anti-PD-L1 therapy as part of a combination treatment for patients with advanced RCC. Around 20-30% of people are diagnosed with advanced RCC, and 30% of people treated for early stage RCC go on to develop advanced disease. This highlights the significant unmet need for effective first-line treatments that delay disease progression and are tolerable for patients.
The approval is based on the results from the open-label phase 3 JAVELIN Renal 101 study involving 886 patients. In this study, median progression-free survival was extended by more than 5 months compared with sunitinib.