FDA Grants Priority Review to Avelumab for Merkel Cell Carcinoma

The FDA has granted a priority review to a biologics license application (BLA) for avelumab as a treatment for patients with metastatic Merkel cell carcinoma (MCC), according to a statement from Merck KGaA and Pfizer, the codevelopers of the PD-L1 inhibitor. The priority review is based on data from the phase II JAVELIN Merkel 200 study, which was presented at the 2016 ASCO Annual Meeting and published in the Lancet Oncology.1,2 In the open-label trial, the objective … (leggi tutto)