FDA grants avelumab fast track designation for metastatic Merkel cell carcinoma
Merck KGaA and Pfizer announced in a press release that the FDA has granted avelumab fast track designation for treating metastatic Merkel cell carcinoma.
Avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, had received orphan drug designation for treating Merkel cell carcinoma (MCC ) on Sept. 21.
The fast track designation was based on a clinical development program for avelumab in metastatic MCC, including a phase 2 study to measure the safety and efficacy in 88 patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen. The study is being conducted in Asia Pacific, Australia, Europe and North America, according to the release. Objective response rate is primary endpoint in the study, duration of response, progression-free survival, overall survival and safety are secondary endpoints, the release reported.
“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, MD, head of global research and development at the biopharmaceutical business of Merck KGaA, said in the release. “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.”
Fast track designation’s purpose is to facilitate development and expedite the review of drugs to treat serious conditions and address an unmet medical need, according to the release.