FDA Grants Avelumab Fast Track Status for Aggressive Skin Cancer
Pfizer and Merck announced that the Food and Drug Administration (FDA) has granted avelumab Fast Track designation for the treatment of metastatic Merkel cell carcinoma (MCC), a rare and aggressive type of skin cancer.
The designation is based on data from the Phase 2 multicenter study, JAVELIN Merkel 200, which assesses the safety and efficacy of avelumab in patients with metastatic MCC who have progressed after at least one prior chemotherapy regimen. The primary endpoint is objective response rate, and secondary endpoints include duration of response, progression-free survival, overall survival and safety.
Avelumab (MSB0010718C) is an investigational fully human anti-PD-L1 IgG1 monoclonal antibody. It was recently granted Orphan Drug designation by the FDA for the treatment of MCC on September 21, 2015.
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