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FDA grants orphan drug designation to avelumab for Merkel cell carcinoma
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The FDA granted orphan drug designation to the investigational immunotherapy avelumab for the treatment of patients with Merkel cell carcinoma.
Avelumab (MSB0010718C, Merck KGaA and Pfizer) — a fully human monoclonal immunoglobulin G1 antibody that targets PD-L1 — is currently under evaluation in the single-arm, open-label, phase 2 JAVELIN Merkel 200 study that is being conducted in Asia Pacific, Australia, Europe and North America. The study is composed of 88 patients with metastatic Merkel cell carcinoma that has progressed after at least one previous chemotherapy regimen.
Objective response rate serves as the study’s primary endpoint. Secondary endpoints include duration of response, PFS, OS and safety.
Researchers are also evaluating avelumab in more than 1,000 patients with 15 different tumor types. Ongoing studies include those for non–small cell lung cancer, renal cell carcinoma and gastric cancer.
“We continue to dedicate significant resources to accelerate our clinical trial program, with a goal of helping patients who are fighting rare and difficult-to-treat diseases, such as Merkel cell carcinoma,” Luciano Rossetti, MD, head of Global Research & Development at Merck Serono, said in a press release. “It is encouraging to be included in the FDA’s orphan drug program as we eagerly await the results of our phase 2 trial of avelumab in this deadly skin cancer.”
The FDA’s Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.