24
Mar

FDA Approves Bavencio for Merkel Cell Carcinoma

Bavencio (avelumab), a PD-L1-inhibitor, gained approval by the Food and Drug Administration (FDA) for some patients with Merkel cell carcinoma.

Bavencio (avelumab), a PD-L1-inhibitor, gained approval by the Food and Drug Administration (FDA) for the treatment of adult and pediatric patients over the age of 12 with metastatic Merkel cell carcinoma, including those who have never had chemotherapy.

The approval is based on data from the phase 2 JAVELIN Merkel 200 study, which was presented at the 2016 ASCO Annual Meeting and published in the Lancet Oncology. In the open-label trial, the objective response rate (ORR) with Bavencio was 31.8 percent, which included a 9.1 percent complete response rate. After a median follow-up of 10.4 months, 82 percent of patients continued to respond to therapy.

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