Merck KGaK and Pfizer Gain FDA Fast Track Designation

Merck KGaA (ETR:MRK) and Pfizer (NYSE:PFE) have announced that they have received FDA Fast Track designation for avelumab, an anti-PD-L1 IgG1 monoclonal antibody for the treatment of metastatic Merkel cell carcinoma.
According to an article on Pharmaceutical Processing:

This announcement builds on the recent FDA Orphan Drugdesignation that was granted for avelumab on September 21, 2015 for the treatment of MCC. The Fast Track designation is designed to facilitate the development, and expedite the review, of drugs to treat serious conditions and address an unmet medical need.
“We are pleased that the FDA continues to acknowledge the current high unmet needs for patients with metastatic Merkel cell carcinoma through these recent regulatory designations for avelumab,” said Dr. Luciano Rossetti, Global Head of Research & Development of the biopharmaceutical business of Merck KGaA, Darmstadt, Germany. “We look forward to working closely with the FDA on an expedited review process for avelumab, and we hope to be able to provide a potential new treatment option for patients with this difficult-to-treat cancer in the future.”
“We look forward to working with our partners at Merck KGaA, Darmstadt, Germany, on the development of avelumab in patients with relapsed and refractory Merkel cell carcinoma,” said Dr. Mace Rothenberg, Senior Vice President of Clinical Development and Medical Affairs and Chief Medical Officer for Pfizer Oncology. “Fast Track designation will enable us to coordinate these efforts more closely with the FDA.”

Click here to read the full article from Pharmaceutical Processing.