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FDA grants avelumab breakthrough therapy designation for metastatic Merkel cell carcinoma
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The FDA granted breakthrough therapy designation to avelumab for the treatment of patients with metastatic Merkel cell carcinoma who progressed after at least one previous chemotherapy regimen, according to a press release from the drug’s manufacturer.
Avelumab (Merck KGaA and Pfizer) — an investigational fully human anti–PD-L1 immunoglobulin G1 monoclonal antibody — also received fast track designation for Merkel cell carcinoma on Oct. 7.
The FDA based its decision in part on a preliminary evaluation of data from a clinical development program for avelumab in metastatic Merkel cell carcinoma, which includes a phase 2 study to measure the agent’s safety and efficacy. The trial — which includes 88 patients with progressive metastatic Merkel cell carcinoma — is being conducted in Asia Pacific, Australia, Europe and North America.
Objective response rate will serve as the primary endpoint of the study. Duration of response, PFS, OS and safety are secondary endpoints.
Data from the trial will be presented at a scientific meeting in 2016, according to the release.
“Metastatic Merkel cell carcinoma is a devastating disease with limited treatment options currently available for patients,” Luciano Rossetti, MD, head of global research and development at the biopharmaceutical business of Merck KGaA, said in the release. “With this breakthrough therapy designation, we are one step closer to our goal of making a significant difference to patients living with difficult-to-treat cancers, such as metastatic Merkel cell carcinoma, by researching and developing potential new treatment options.”