Posted by Michael Wonder on 29 Nov 2016
FDA accepts the biologics license application for avelumab for the treatment of metastatic Merkel cell carcinoma for priority review
29 November 2016 - Avelumab has previously received FDA breakthrough therapy and fast track designations for metastatic Merkel cell carcinoma, as well as FDA orphan drug designation for Merkel cell carcinoma.
Merck and Pfizer today announced that the US FDA has accepted for priority review the biologics license application for avelumab, which was submitted by EMD Serono, the biopharmaceutical business of Merck in the US and Canada. This review relates to avelumab’s proposed use in patients with metastatic Merkel cell carcinoma, based on tumour response results from the JAVELIN Merkel 200 trial.
Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody and could be the first treatment indicated for metastatic MCC in the US, if approved.
