EMA validates BMS’ type II variation application for Opdivo in advanced form of bladder cancer

The European Medicines Agency (EMA) validated Bristol-Myers Squibb’s (BMS) type II variation application, which seeks to extend the current indications for Opdivo to include the treatment of locally advanced unresectable or metastatic urothelial carcinoma (mUC) in adults after failure of prior platinum-containing therapy. http://drugdelivery.pharmaceutical-business-review.com/news/ema-validates-bms-type-ii-variation-application-for-opdivo-in-advanced-form-of-bladder-cancer-210916-5011455