Merck and Pfizer announce new Fast Track designation for Merkel cell treatment

Merck KGaA, Darmstadt, Germany and Pfizer on Wednesday announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to avelumab, a treatment for metastatic Merkel cell carcinoma.

Avelumab is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody.

“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,” Luciano Rossetti, global head of research and development of the biopharmaceutical business of Merck KGaA, said. “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.”

The announcement builds on the recent FDA Orphan Drug designation that was granted for avelumab on Sept. 21 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 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,” Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology, said. “Fast Track designation will enable us to coordinate these efforts more closely with the FDA.”