Avelumab, an investigational treatment for metastatic Merkel cell carcinoma (MCC) being developed by Merck KGaA and Pfizer, has been granted fast track designation by the U.S. Food and Drug Administration (FDA) to accelerate its development and transition into an effective therapy for patients with this type of tumor.
The two companies recently announced that the FDA status was granted to the investigational fully human anti-PD-L1 IgG1 monoclonal antibody treatment, which had already received an orphan drug designation. “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,” stated the head of global research and development at the biopharmaceutical business of Merck KGaA, Luciano Rossetti, MD.
“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,” added Rossetti. The FDA ‘s decision was based on data from avelumab’s clinical development program in metastatic MCC. The study is currently ongoing and includes a phase 2 trial taking place in Asia Pacific, Australia, Europe and North America. The trial aims to evaluate avelumab’s safety and efficacy in 88 patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen. The primary endpoint of the trial is objective response rate, and duration of response, progression-free survival, overall survival and safety account for the secondary endpoints.
By granting avelumab fast track designation, the FDA aims to facilitate its development and expedite its review. Because the drug has received a fast track designation, the FDA, Merck and Pfizer will have earlier and more frequent communications throughout the developmental and review process, which is expected to assure questions and issues are resolved quickly leading to earlier approval and patients’ access.