FDA Grants Priority Review to Keytruda for Patients with High-Risk, Non–Muscle-Invasive Bladder Cancer
The FDA has granted priority review to Merck’s supplemental Biologics License Application for the anti-PD–1 agent pembrolizumab as monotherapy for certain patients with high-risk, non-muscle invasive bladder cancer who are ineligible for or have elected not to undergo cystectomy.
Imfinzi (Durvalumab) a New PD-L1 Inhibitor Approved for the Treatment of Advanced or Metastatic Urothelial Cancer
On May 1, 2017, the FDA granted accelerated approval to durvalumab (Imfinzi; AstraZeneca), an intravenous (IV) PD-L1 inhibitor, for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or after platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.
Tecentriq (Atezolizumab) Receives New Indication for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma
On April 17, 2017, the US Food and Drug Administration (FDA) granted accelerated approval to atezolizumab (Tecentriq; Genentech), a monoclonal antibody intravenous (IV) inhibitor of programmed-cell death ligand-1 (PD-L1), as detected by the FDA-approved test, as a front-line treatment for patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin chemotherapy.
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