The filing is based on the CheckMate-901 trial, which showed that adding PD-1 inhibitor Opdivo (nivolumab) to standard first-line cisplatin and gemcitabine chemotherapy improved survival in cisplatin-eligible patients with untreated, unresectable, or metastatic UC, the most common form of bladder cancer.
The review has started just a few days after the FDA kicked off a priority review of MSD/Merck & Co’s PD-1 inhibitor Keytruda (pembrolizumab) in combination with Seagen’s nectin-4-directed antibody-drug conjugate (ADC) as a chemo-free option for previously untreated, locally advanced, or metastatic UC.
