Prodotti competitors / Area Onco-Ema
Pembrolizumab: FDA Grants Curtailed mUC Full Approval
![Immagine News](/media/l4el5htd/cat-2.jpg?anchor=center&mode=crop&width=722&height=442)
Today the FDA announced the full approval of pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for any platinum-containing chemotherapy. The full approval conversion limits the use of pembrolizumab to a smaller subset of patients in the 1L setting (platinum ineligible) vs. the previous accelerated approval; which was in PD-L1+ cisplatin-ineligible patients. The limitation is a result of pembrolizumab failing a confirmatory study in this setting.
Grazie per il tuo feedback!