CHMP Adopts Positive Opinion Recommending Approval of Bristol Myers Squibb's Opdivo® (nivolumab) in Combination with Cisplatin and Gemcitabine for the First-Line Treatment of Adult Patients with Unresectable or Metastatic Urothelial Carcinoma
Recommendation based on results from CheckMate -901, the first Phase 3 trial with an immunotherapy-chemotherapy combination to demonstrate a survival benefit versus standard-of-care chemotherapy...