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FDA Grants Avelumab Priority Review for Metastatic Urothelial Carcinoma

Jason M. Broderick @jasoncology
Published: Tuesday, Feb 28, 2017

Dr Luciano Rossetti

Luciano Rossetti, MD

The FDA has granted a priority review to a biologics license application (BLA) for avelumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) whose disease has progressed after platinum-based therapy, according to Merck KGaA and Pfizer, the codevelopers of the PD-L1 inhibitor.

In November 2016, the FDA granted a priority review to a BLA for avelumab for use as a treatment for patients with metastatic Merkel cell carcinoma.
Apolo AB, Infante JR, Hamid O, et al. Safety, clinical activity, and PD-L1 expression of avelumab (MSB0010718C), an anti-PD-L1 antibody, in patients with metastatic urothelial carcinoma from the JAVELIN Solid Tumor phase Ib trial. J Clin Oncol. 2016;34 (suppl 2S; abstr 367).

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