In April 2017, the FDA approved the first-ever drug treatment for the rare and aggressive skin cancer Merkel cell carcinoma (MCC). The immunotherapy drug avelumab (Bavencio, EMD Serono/Pfizer) was approved based on the results of a multicenter, open-label, phase 2 trial as well as data from a real-world retrospective analysis of patients with metastatic MCC treated with chemotherapy.
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MCC Rx Marks First Use of Real-World Data for FDA Approval
In April 2017, the FDA approved the first-ever drug treatment for the rare and aggressive skin cancer Merkel cell carcinoma (MCC). The immunotherapy drug avelumab (Bavencio, EMD Serono/Pfizer) was approved based on the results of a multicenter, open-label, phase 2 trial as well as data from a real-world retrospective analysis of patients with metastatic MCC treated with chemotherapy.