Merck and Pfizer announced that the Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to avelumab for the treatment of patients with metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer, who have progressed after at least one previous chemotherapy regimen.
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The designation is based on preliminary findings from the global Phase 2 study, JAVELIN Merkel 200, which assessed the safety and efficacy of avelumab in patients with metastatic MCC whose disease has progressed after at least one prior chemotherapy regimen. JAVELIN Merkel 200 is a multicenter, single-arm, open-label study with a primary objective of overall response rate. The companies anticipate to present detailed results of the study at upcoming scientific congresses in 2016.
Avelumab (MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody.
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