Pembrolizumab & Bladder cancer

FDA status:

In the context of Pembrolizumab & Bladder cancer, approved for locally advanced or metastatic Bladder cancer as 2L therapy that has progressed during or after platinum‑containing chemotherapy, based mainly on KEYNOTE‑045 (1, 2, 3). Additionally, it is approved (with a label later restricted) for patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin‑containing chemotherapy (1L therapy), using PD‑L1 and risk‑based criteria (2, 4). It is approved for BCG‑unresponsive, high‑risk non–muscle‑invasive bladder cancer with carcinoma in situ (with or without papillary tumors) in patients inelig…