FDA Grants Atezolizumab Priority Review for Second Bladder Cancer Indication

9 gennaio 2017 – The FDA has granted a priority review to a supplemental new drug application (sNDA) for the use of the PD-L1 inhibitor atezolizumab (Tecentriq) in cisplatin-ineligible patients with locally advanced or metastatic urothelial carcinoma (mUC) as a frontline therapy or following progression occurring ≥12 months after neoadjuvant or adjuvant chemotherapy. The sNDA is based on data from the single-arm phase II IMvigor210 trial. In a study cohort of 119 … (leggi tutto)